Quassia: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag=<!--Overview-->{{RB}}
|OTC=Yes
|genericName=Quassia
|aOrAn=a
|aOrAn=a
|drugClass=OTC cream
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication=head lice, pubic (crab lice) and body lice
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=eye irritation, skin or scalp irritation
 
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
 


<!--Adult Indications and Dosage-->
<!--Adult Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=====Indications====
 
* treats head lice, pubic (crab lice) and body lice
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:


* Strength of Evidence:  
====Dosage====
Important: Read warnings and full directions. For more information read the enclosed Consumer Information Leaflet.
For adults and children 6 months and over.


* Dosing Information
APPLY
 
apply the entire contents of one tube thoroughly to dry hair, starting from behind the ears to the back of the neck, working forward.
:* Dosage
to be effective, all lice and eggs must come in contact with product, ensure hair and scalp are saturated. For long or very thick hair two tubes may be required.
 
COVER
=====Condition2=====
use the shower cap supplied to keep hair damp, leave on for 4 hours before washing.
 
for serious infestation remove shower cap after 4 hours and leave product on overnight.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
WASH
wash area thoroughly with warm water and regular shampoo. Towel hair dry and comb out tangles using a regular comb or brush.
as an option remove any remaining lice or nits with the included nit comb or fingernails.
if hair dries during combing dampen slightly with water.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=====Dosage====
Important: Read warnings and full directions. For more information read the enclosed Consumer Information Leaflet.
For adults and children 6 months and over.


* Dosing Information
APPLY
 
apply the entire contents of one tube thoroughly to dry hair, starting from behind the ears to the back of the neck, working forward.
:* Dosage
to be effective, all lice and eggs must come in contact with product, ensure hair and scalp are saturated. For long or very thick hair two tubes may be required.
 
COVER
=====Condition2=====
use the shower cap supplied to keep hair damp, leave on for 4 hours before washing.
 
for serious infestation remove shower cap after 4 hours and leave product on overnight.
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
WASH
wash area thoroughly with warm water and regular shampoo. Towel hair dry and comb out tangles using a regular comb or brush.
as an option remove any remaining lice or nits with the included nit comb or fingernails.
if hair dries during combing dampen slightly with water.


<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


* Dosing Information
<!--Contraindications-->
|contraindications=


:* Dosage
<!--Warnings-->
|warnings=* For external use only.
DO NOT USE
near eyes
inside the nose, mouth or vagina
on lice in eyebrows or eyelashes
See a doctor if lice are present in these areas.


=====Condition2=====


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
WHEN USING THIS PRODUCT
|contraindications=* Condition1
keep tightly closed and protect eyes with a washcloth or towel.
if product gets into the eyes, flush with water right away.
STOP USE AND ASK A DOCTOR IF
eye irritation occurs
skin or scalp irritation continues or infection occurs


<!--Warnings-->
|warnings=* Description


====Precautions====
KEEP OUT OF REACH OF CHILDREN
 
If swallowed, get medical help or contact a Poison Control Center right away.
* Description


<!--Adverse Reactions-->
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=* eye irritation
 
* skin or scalp irritation
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


Line 245: Line 151:


<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=
:* Description


<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
Line 265: Line 170:


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Topical application
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description


<!--IV Compatibility-->
<!--IV Compatibility-->
Line 276: Line 179:


<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
<!--Pharmacology-->
Line 297: Line 188:


<!--Structure-->
<!--Structure-->
|structure=*  
|structure=* ACTIVE INGREDIENTS
Quassia amara 2X HPUS (Amargo 200mcg/g)
 
INACTIVE INGREDIENTS
 
aqua, cetearyl alcohol, dimethicone, fragrance, cetrimonium bromide, citric acid
 


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
Line 315: Line 211:
<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|storage=keep carton for important product information
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
protect from excessive heat
|packLabel=
PACKAGING INFORMATION
Quit Nits®
Caring for your child, naturally


<!--Precautions with Alcohol-->
2.03 FL  OZ (60mL)
 
ADVANCE
Kills head lice and eggs with one application
 
WILD CHILD®
Born, not made.
 
Ingredients Incl: Aqua, cetearyl alcohol, dimethicone, fragrance, cetrimonium bromide, citric acid, quassia wood jamaican extract.
4 simple steps to help eliminate Head Lice Infestation:
 
APPLY - Massage cream through dry hair and onto scalp, ensuring all of the hair and the back of the neck is wet with product.
 
COVER - Use shower cap supplied to keep hair damp and leave on for 4 hours. For serious infestation remove cap and leave treatment on overnight.
 
WASH - after 4 hours use your regular shampoo to remove the product. Any remaining lice and eggs should be removed with fingernails.
 
FOLLOW-UP try Quit Nits Every Day Lice Preventative Spray to limit re-infestation.
 
For external use only. Avoid contact with eyes. If product gets into eyes, rinse well with water. If irritation occurs, discontinue use.
 
Manufactured for:
Wild Child (US) Pty Ltd
by The Triad Group
Hartland, WI 53029
info@wildchildonline.com
800.961.4936
 
For batch and expiry date see crimp
 
: [[File:Quassia PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
 
: [[File:Quassia Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Patient Counseling Information-->
|fdaPatientInfo=800-961-4936 or
 
support@QuitNits.com
 
www.QuitNits.com
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=* QUIT NITS ADVANCE®<ref>{{Cite web | title = Quassia amara | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=36682}}</ref>


<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Revision as of 14:39, 19 February 2015

Quassia
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Quassia is a OTC cream that is FDA approved for the treatment of head lice, pubic (crab lice) and body lice. Common adverse reactions include eye irritation, skin or scalp irritation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • treats head lice, pubic (crab lice) and body lice

Dosage

Important: Read warnings and full directions. For more information read the enclosed Consumer Information Leaflet. For adults and children 6 months and over.

APPLY apply the entire contents of one tube thoroughly to dry hair, starting from behind the ears to the back of the neck, working forward. to be effective, all lice and eggs must come in contact with product, ensure hair and scalp are saturated. For long or very thick hair two tubes may be required. COVER use the shower cap supplied to keep hair damp, leave on for 4 hours before washing. for serious infestation remove shower cap after 4 hours and leave product on overnight. WASH wash area thoroughly with warm water and regular shampoo. Towel hair dry and comb out tangles using a regular comb or brush. as an option remove any remaining lice or nits with the included nit comb or fingernails. if hair dries during combing dampen slightly with water.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Quassia in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Quassia in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Dosage

Important: Read warnings and full directions. For more information read the enclosed Consumer Information Leaflet. For adults and children 6 months and over.

APPLY apply the entire contents of one tube thoroughly to dry hair, starting from behind the ears to the back of the neck, working forward. to be effective, all lice and eggs must come in contact with product, ensure hair and scalp are saturated. For long or very thick hair two tubes may be required. COVER use the shower cap supplied to keep hair damp, leave on for 4 hours before washing. for serious infestation remove shower cap after 4 hours and leave product on overnight. WASH wash area thoroughly with warm water and regular shampoo. Towel hair dry and comb out tangles using a regular comb or brush. as an option remove any remaining lice or nits with the included nit comb or fingernails. if hair dries during combing dampen slightly with water.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Quassia in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Quassia in pediatric patients.

Contraindications

There is limited information regarding Quassia Contraindications in the drug label.

Warnings

  • For external use only.

DO NOT USE near eyes inside the nose, mouth or vagina on lice in eyebrows or eyelashes See a doctor if lice are present in these areas.


WHEN USING THIS PRODUCT keep tightly closed and protect eyes with a washcloth or towel. if product gets into the eyes, flush with water right away. STOP USE AND ASK A DOCTOR IF eye irritation occurs skin or scalp irritation continues or infection occurs


KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

  • eye irritation
  • skin or scalp irritation

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Quassia in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

There is limited information regarding Quassia Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Quassia in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Quassia during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Quassia with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Quassia with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Quassia with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Quassia with respect to specific gender populations.

Race

There is no FDA guidance on the use of Quassia with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Quassia in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Quassia in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Quassia in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Quassia in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Topical application

Monitoring

There is limited information regarding Monitoring of Quassia in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Quassia in the drug label.

Overdosage

There is limited information regarding Overdose of Quassia in the drug label.

Pharmacology

There is limited information regarding Quassia Pharmacology in the drug label.

Mechanism of Action

Structure

  • ACTIVE INGREDIENTS

Quassia amara 2X HPUS (Amargo 200mcg/g)

INACTIVE INGREDIENTS

aqua, cetearyl alcohol, dimethicone, fragrance, cetrimonium bromide, citric acid

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Quassia in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Quassia in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Quassia in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Quassia in the drug label.

How Supplied

Storage

keep carton for important product information protect from excessive heat

Images

Drug Images

{{#ask: Page Name::Quassia |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PACKAGING INFORMATION Quit Nits® Caring for your child, naturally

2.03 FL OZ (60mL)

ADVANCE Kills head lice and eggs with one application

WILD CHILD® Born, not made.

Ingredients Incl: Aqua, cetearyl alcohol, dimethicone, fragrance, cetrimonium bromide, citric acid, quassia wood jamaican extract. 4 simple steps to help eliminate Head Lice Infestation:

APPLY - Massage cream through dry hair and onto scalp, ensuring all of the hair and the back of the neck is wet with product.

COVER - Use shower cap supplied to keep hair damp and leave on for 4 hours. For serious infestation remove cap and leave treatment on overnight.

WASH - after 4 hours use your regular shampoo to remove the product. Any remaining lice and eggs should be removed with fingernails.

FOLLOW-UP try Quit Nits Every Day Lice Preventative Spray to limit re-infestation.

For external use only. Avoid contact with eyes. If product gets into eyes, rinse well with water. If irritation occurs, discontinue use.

Manufactured for: Wild Child (US) Pty Ltd by The Triad Group Hartland, WI 53029 info@wildchildonline.com 800.961.4936

For batch and expiry date see crimp

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Quassia |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

800-961-4936 or

support@QuitNits.com

www.QuitNits.com

Precautions with Alcohol

  • Alcohol-Quassia interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • QUIT NITS ADVANCE®[1]

Look-Alike Drug Names

There is limited information regarding Quassia Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "Quassia amara".

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