Label: CAPSAICIN CREAM- capsaicin cream
- NDC Code(s): 69396-103-02
- Packager: Trifecta Pharmaceuticals USA LLC
- Category: HUMAN OTC DRUG LABEL
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 May 5, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
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Warnings
For external use only: TEST FIRST ON SMALL AREA OF SKIN.
When using this product:
- Use only as directed
- Do not apply to wounds, damaged, broken or irritated skin
- Avoid contact with the eyes or mucous membranes
- A slight burning sensation may occur upon application, but generally disappears after several days
- If severe burning occurs, discontinue use
- Do not expose the treated area to heat or direct sunlight
- Do not bandage
- Do not use with heating pad
- Do not use at the same time as other topical analgesics
- Stop Use and Ask Doctor
- Keep Out of the Reach of Children
- Uses
- If Pregnant or Breast Feeding
- Directions
- Inactive Ingredients
- Other Information
- Questions
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAPSAICIN CREAM
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-103 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 LAURETH-23 (UNII: N72LMW566G) STEARIC ACID (UNII: 4ELV7Z65AP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALOE VERA LEAF (UNII: ZY81Z83H0X) ETHYLPARABEN (UNII: 14255EXE39) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-103-02 1 in 1 BOX 05/14/2022 1 60 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 05/14/2022 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)