Dimethicone: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{RB}}
|OTC=Yes
|genericName=Dimethicone
|aOrAn=a
|aOrAn=a
|drugClass=dermatological agent
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication=diaper dermatitis, cracked skin and lips
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=burning, stinging, redness, or 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====
 
Helps treat and prevent diaper dermatitis
* Dosing Information
Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness
 
Temporarily protects and helps relieve chapped or cracked skin and lips
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->


<!--Guideline-Supported Use (Adult)-->
====Directions====
|offLabelAdultGuideSupport======Condition1=====
Apply as needed
 
Change wet and soiled diapers, garments, and linens promptly
* Developed by:
Cleanse the affected area and allow to dry
 
Apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged
* Class of Recommendation:
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
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=====Indications====
 
Helps treat and prevent diaper dermatitis
* Dosing Information
Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness
 
Temporarily protects and helps relieve chapped or cracked skin and lips
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* 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.
====Directions====
Apply as needed
Change wet and soiled diapers, garments, and linens promptly
Cleanse the affected area and allow to dry
Apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged
|offLabelPedGuideSupport=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
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=


<!--Warnings-->
<!--Warnings-->
|warnings=* Description
|warnings=* For external use only
 
====Precautions====


* Description
When using this product
do not get into eyes
Stop use and ask a doctor if
condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
Do not use on
deep or puncture wounds
animal bites
serious burns
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center immediately


<!--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=burning, stinging, redness, or 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 244: Line 129:


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


<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
Line 264: Line 148:


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


Line 275: Line 157:


<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=There is limited information regarding <i>Chronic 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 296: Line 166:


<!--Structure-->
<!--Structure-->
|structure=*  
|structure=* ACTIVE INGREDIENTS
Dimethicone 5%
 
INACTIVE INGREDIENTS
water, petrolatum, isopropyl palmitate, propylene glycol, cetyl dimethicone copolyol, hexyl laurate, polyglycerol-4 isostearate, sodium chloride, paraffin, hydrogenated castor oil, beeswax, methylparaben, disodium EDTA, propylparaben
 


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


<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
Line 314: Line 188:
<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|packLabel=====PRINCIPAL DISPLAY PANEL====
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


<!--Precautions with Alcohol-->
: [[File:Dimethicone PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
: [[File:Dimethicone Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Patient Counseling Information-->
|fdaPatientInfo=QUESTION OR COMMENTS?
1 800 876-1261
|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=* SECURA DIMETHICONE PROTECTANT®<ref>{{Cite web | title = Dimethicone | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=37eadaaa-f2ad-4c8b-babf-3762c9ff777b}}</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 14:04, 2 April 2015

Dimethicone
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

Dimethicone is a dermatological agent that is FDA approved for the treatment of diaper dermatitis, cracked skin and lips. Common adverse reactions include burning, stinging, redness, or irritation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Helps treat and prevent diaper dermatitis Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness Temporarily protects and helps relieve chapped or cracked skin and lips

Directions

Apply as needed Change wet and soiled diapers, garments, and linens promptly Cleanse the affected area and allow to dry Apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Helps treat and prevent diaper dermatitis Protects minor skin irritation associated with diaper dermatitis and helps protect from wetness Temporarily protects and helps relieve chapped or cracked skin and lips

Directions

Apply as needed Change wet and soiled diapers, garments, and linens promptly Cleanse the affected area and allow to dry Apply cream liberally as often as necessary with each diaper, garment or linen change; especially at bedtime or anytime when exposure to soiled diapers, garments, linens, feces, or urine may be prolonged

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

  • For external use only

When using this product 

do not get into eyes

Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Do not use on deep or puncture wounds animal bites serious burns Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately

Adverse Reactions

Clinical Trials Experience

burning, stinging, redness, or irritation

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Dimethicone 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 Dimethicone 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 Dimethicone in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • topical

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

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

Pharmacology

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

Mechanism of Action

Structure

  • ACTIVE INGREDIENTS

Dimethicone 5%

INACTIVE INGREDIENTS water, petrolatum, isopropyl palmitate, propylene glycol, cetyl dimethicone copolyol, hexyl laurate, polyglycerol-4 isostearate, sodium chloride, paraffin, hydrogenated castor oil, beeswax, methylparaben, disodium EDTA, propylparaben

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Dimethicone Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Dimethicone |?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

PRINCIPAL DISPLAY PANEL

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::Dimethicone |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

QUESTION OR COMMENTS? 1 800 876-1261

Precautions with Alcohol

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

Brand Names

  • SECURA DIMETHICONE PROTECTANT®[1]

Look-Alike Drug Names

There is limited information regarding Dimethicone 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. ↑ "Dimethicone".

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