Dimethicone

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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
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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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

## 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

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL

### Ingredients and Appearance

# Patient Counseling Information
QUESTION OR COMMENTS?

# 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