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).
Background
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 |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cardinal Health 107, LLC | 55154-9429 | ORAL | 20 mg in 5 mL | 5/1/2025 | |
| 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
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||