Label: CAPSAICIN CREAM- capsaicin cream
- NDC Code(s): 73141-558-02
- Packager: A2A Integrated Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 1, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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 capsaicin or chili peppers
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 treated area
- do not apply heat to the treated area immediately before or after use.
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Directions
Directions
Adults and children 18 years of age and older:
- apply a thin film of cream to affected area and gently tub 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
- Other Information
- Inactive Ingredients
- Questions or comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAPSAICIN CREAM
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73141-558 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 XANTHAN GUM (UNII: TTV12P4NEE) CETYL ALCOHOL (UNII: 936JST6JCN) PEG-100 STEARATE (UNII: YD01N1999R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) ALOE VERA LEAF (UNII: ZY81Z83H0X) WHITE PETROLATUM (UNII: B6E5W8RQJ4) PEPPERMINT OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PHENOXYETHANOL (UNII: HIE492ZZ3T) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73141-558-02 1 in 1 BOX 03/25/2024 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 03/25/2024 Labeler - A2A Integrated Pharmaceuticals, LLC (117064671) Establishment Name Address ID/FEI Business Operations Quality CDMO 117658386 manufacture(73141-558) , pack(73141-558)
