Label: CAPSAICIN cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 17, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Capsaicin 0.025%

  • Purpose

    External Analgesic

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints due to: simple backache, arthritis, strains, sprains

  • 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

  • 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

    • Store at room temperature 15°-30°C (59°-86°F).
    • Protect product from excessive moisture.
  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79643-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79643-006-01100 g in 1 TUBE; Type 0: Not a Combination Product01/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/24/2024
    Labeler - PHARMACURE LLC (055983858)