Label: CAPSAICIN EXTERNAL ANALGESIC- capsaicin cream
- NDC Code(s): 50268-195-60
- 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.
Updated December 8, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
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
Stop use and ask a doctor if
- condition worsens or does not improve after regular use
- severe burning persists
- redness or blistering occurs
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
INGREDIENTS AND APPEARANCE
CAPSAICIN EXTERNAL ANALGESIC
Product 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) 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) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) 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 not final part348 12/08/2022 Labeler - AvPAK (832926666)