Label: CAPSAICIN cream
- NDC Code(s): 50268-197-56
- 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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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings: For external use only.
Do not use:
- on wounds or damaged skin
- if you are allergic to capsicum or chili peppers
- with heating pad
When using this produce:
- you may experience a burning sensation The intensity of this reaction varies among individuals and may be severe. With regular use, the sensation generally disappears after several days.
- avoid contact with the eyes, lips, nose and mucous membranes
- do not tightly wrap or bandage the treatement area
- do not apply heat, or direct sunlight to the treated area immediately before or after use
Stop use and ask a doctor if:
- condition worsens or does not improve after regular use
- severe burning persists
- redness or blistering occurs
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DOSAGE & ADMINISTRATION
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. - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
CAPSAICIN
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50268-197 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.001 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) PETROLATUM (UNII: 4T6H12BN9U) PEPPERMINT OIL (UNII: AV092KU4JH) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MINERAL OIL (UNII: T5L8T28FGP) ALOE VERA LEAF (UNII: ZY81Z83H0X) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50268-197-56 1 in 1 CARTON 12/08/2022 1 56.6 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)