Label: CAPSAICIN cream
- NDC Code(s): 79643-006-01
- Packager: PHARMACURE LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 17, 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 capsicum 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.
Stop use and ask a doctor if
• Conditions worsens or does not improve after regular use.
• Severe burning persists o blistering occurs.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
- KEEP OUT OF REACH OF CHILDREN
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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
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Inactive ingredients
Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, sodium laurylglucosides hydroxypropylsulfonate, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbitan olivate, stearic acid
- Product label
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INGREDIENTS AND APPEARANCE
CAPSAICIN
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79643-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ) CETEARYL OLIVATE (UNII: 58B69Q84JO) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HEMP (UNII: TD1MUT01Q7) PEG-100 MONOSTEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) RESVERATROL (UNII: Q369O8926L) SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: Z6GFR7R72Y) SORBITAN OLIVATE (UNII: MDL271E3GR) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79643-006-01 100 g in 1 TUBE; Type 0: Not a Combination Product 01/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 01/24/2024 Labeler - PHARMACURE LLC (055983858)