Label: CAPSAICIN EXTERNAL ANALGESIC- capsaicin cream
- NDC Code(s): 50268-195-60
- Packager: AvPAK
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 6, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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 capsicum or chili peppers
- with heating pad
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
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
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
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INGREDIENTS AND APPEARANCE
CAPSAICIN EXTERNAL ANALGESIC
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50268-195 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CETYL ALCOHOL (UNII: 936JST6JCN) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) PETROLATUM (UNII: 4T6H12BN9U) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE) PEPPERMINT OIL (UNII: AV092KU4JH) ALOE VERA LEAF (UNII: ZY81Z83H0X) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50268-195-60 1 in 1 CARTON 12/08/2022 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 12/08/2022 Labeler - AvPAK (832926666)