Label: CAPSAICIN 0.075% CREAM- capsaicin cream
- NDC Code(s): 85231-202-60
- Packager: ViolaCare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 4, 2025
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- Official Label (Printer Friendly)
- Drug facts Active Ingredient Purpose
- PURPOSE
- Uses
-
Warnings
For external use only. Read all warnings and directions before use. Test first on small area of the skin.
Do not use
- on wounds or damaged skin
- if you are allergic to capsaicum 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 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
Stop use and ask doctor if
- condition worsens or does not improve after regular use
- severe burning persists or blistering occurs
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DOSAGE & ADMINISTRATION
Directions adults and children 18 years and older:
- apply a thin film of cream to the 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
- ASK DOCTOR
- Other information
- Inactive Ingredients
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CAPSAICIN 0.075% CREAM
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:85231-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.075 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL STEARATE (UNII: 230OU9XXE4) MINERAL OIL (UNII: T5L8T28FGP) PEG-100 STEARATE (UNII: YD01N1999R) PEPPERMINT OIL (UNII: AV092KU4JH) PETROLATUM (UNII: 4T6H12BN9U) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:85231-202-60 1 in 1 CARTON 06/02/2025 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 06/02/2025 Labeler - ViolaCare, Inc. (119452160)


