Quassia

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]

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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.

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

This image is provided by the Wikipedia.

Mechanism of Action

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

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

There is limited information regarding Quassia How Supplied in the drug label.

Storage

• keep carton for important product information
• protect from excessive heat

Images

Drug Images

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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.

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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®

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.