Label: CAPSAICIN TOPICAL ANALGESIC- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Capsaicin 0.075%

  • Purpose

    Topical 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
    • 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 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 and ask a doctor if

    • condition worsens or does not improve after regular use
    • severe burning persists
    • redness or blistering occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • 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°F – 86°F).

  • Inactive ingredients

    Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum

  • Questions or comments?

    1-855-361-3993

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    AvKARE, Pulaski, TN 38478

    www.avkare.com

    AV 06/22

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

    57

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN  TOPICAL ANALGESIC
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-196
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-196-571 in 1 CARTON12/08/2022
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/08/2022
    Labeler - AvPAK (832926666)
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