Overview
Dimethicone is a silicone-based polymer used as a moisturizer in different skin OTC products. It is formed by repeated polymeric units of -(CH3)2SiO- with a terminal trimethyl siloxy unit. It is currently recognized by the FDA as a skin protectant OTC ingredient for human use in a concentration of 1-30%. The name dimethicone has a lot of nomenclature inconsistencies as it is used to refer to common names, generic names, trade names or even for the listing of mixtures. It is reported that the term dimethicone includes the notation of polydimethylsiloxane and trimethylsiloxy-terminated fluids between 20-30,000 cSt (viscosity).
Indication
Dimethicone is approved as a transdermal drug delivery system. Dimethicone 410 is part of the simethicone element in Dow Corning Q7-2242 LVA which is an antifoam. Some OTC's containing dimethicone are used to relieve the discomfort of infant gas caused by air swallowing or certain formulas or food, to prevent and help rash, to protect and relieve chapped or cracked skin and as an anti-lice agent.
Associated Conditions
- Diaper Rash
- Dry Skin
- Impetigo caused by Staphylococcus aureus
- Impetigo caused by streptococcus pyogenes
- Skin Irritation
- Skin chapped
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Blistex Inc | 10157-4104 | TOPICAL | 2 g in 100 g | 7/18/2025 | |
| KROGER COMPANY | 30142-481 | ORAL | 125 mg in 1 1 | 8/1/2025 | |
| Cardinal Health 107, LLC | 55154-9429 | ORAL | 20 mg in 5 mL | 5/1/2025 | |
| THE KROGER CO. | 30142-171 | ORAL | 20 mg in 0.3 mL | 8/1/2025 | |
| KROGER COMPANY | 30142-330 | ORAL | 125 mg in 1 1 | 8/1/2025 | |
| KRAMER LABORATORIES | 55505-225 | ORAL | 125 mg in 5 mL | 4/17/2025 | |
| DOLGENCORP, LLC | 55910-670 | ORAL | 80 mg in 10 mL | 4/8/2025 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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