Dimethicone

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]

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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.

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

This image is provided by the Wikipedia.

Mechanism of Action

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

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

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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.

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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®

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.