Label: CAPSAICIN cream
- NDC Code(s): 50268-198-42
- Packager: AvPAK
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 8, 2022
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- Drug Facts
- Active Ingredient
- Purpose
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Warnings
For external use only: Read all warnings and directions before use. Test first on small area of skin.
Do not use:
- on wounds or damaged skin
- if you are allergic to capsicum or chili peppers
- do not use with heating pad or expose area to sunlight
When using this product:
- you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
- avoid contact with the eyes, lips, nose and mucous membranes
- do not tightly wrap or bandage the treatment area
- do not apply heat to the treated area immediately before or after use
- Stop Use and Ask Doctor
- Keep Out of the Reach of Children
- Uses
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Directions
Adults and Children 18 years of age and older:
- apply a thin film of cream to affected area and gently rub in until fully absorbed
- unless treating hands, wash hands thoroughly with soap and water immediately after application
- for best results, apply 3 to 4 times daily
Children under 18 years:
Ask a doctor
- Inactive Ingredients
- Questions
- Other Information
- Packaging
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INGREDIENTS AND APPEARANCE
CAPSAICIN
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50268-198 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) ALOE VERA LEAF (UNII: ZY81Z83H0X) XANTHAN GUM (UNII: TTV12P4NEE) MINERAL OIL (UNII: T5L8T28FGP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEPPERMINT OIL (UNII: AV092KU4JH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50268-198-42 1 in 1 CARTON 12/08/2022 1 42.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/08/2022 Labeler - AvPAK (832926666)