Label: CAPSAICIN cream

  • 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.

Drug Label Information

Updated December 8, 2022

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Capsaicin 0.1%

  • Purpose

    Topical Analgesic

  • 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
    • do not use with heating pad or expose area to sunlight

    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 treatment area
    • do not apply heat to the treated area immediately before or after use
  • Stop Use and Ask Doctor

    Stope Use and Ask Doctor if:

    • Condition worsens or does not improve after regular use
    • severe burning persists
    • redness or blistering occurs
  • Keep Out of the Reach of Children

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

  • Uses

    Temporarily relieves minor aches and pains of muscles and joints due to:

    • simple backache
    • arthritis
    • strains
    • sprains
  • 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

  • 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

    Questions? Comments?

    1-855-361-3993

    Manufactured for:

    AvKARE, Pulaski, TN 38478

    www.avkare.com

    AV 06/22

  • Other Information

    Store at room temperature 15°-30°F (59°-86°F)

  • Packaging

    42

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-198
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-198-421 in 1 CARTON12/08/2022
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/08/2022
    Labeler - AvPAK (832926666)