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.

  • ACTIVE INGREDIENT

    Active Ingredient: Capsaicin 0.1%

  • PURPOSE

    Purpose: Topical Analgesic

  • INDICATIONS & USAGE

    Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

  • WARNINGS

    Warnings: For external use only.

    Do not use:

    • on wounds or damaged skin
    • if you are allergic to capsicum or chili peppers
    • with heating pad

    When using this produce:

    • you may experience a burning sensation The intensity of this reaction varies among individuals and may be severe. With regular use, the sensation generally disappears after several days.
    • avoid contact with the eyes, lips, nose and mucous membranes
    • do not tightly wrap or bandage the treatement area
    • do not apply heat, or direct sunlight 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

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

  • DOSAGE & ADMINISTRATION

    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.

  • STORAGE AND HANDLING

    Other Information:store at room temperature 15° - 30°C (59° - 86°F)

  • INACTIVE INGREDIENT

    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

  • SPL UNCLASSIFIED SECTION

    Questions? Comments?

    1-855-361-3993

    Manufactured for:

    AvKARE, Pulaski, TN 38478

    www.avkare.com

    AV 06/22

  • Packaging

    56

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-197
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.001 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-197-561 in 1 CARTON12/08/2022
    156.6 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)