Label: CAPSAICIN CREAM- capsaicin cream
- NDC Code(s): 69396-103-02
- Packager: Trifecta Pharmaceuticals USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 2024
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- 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 Drug M017 05/14/2022 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)