Dimethicone
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
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
- 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
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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®[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.
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