Label: CAPSAICIN 0.075% CREAM- capsaicin cream

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

Drug Label Information

Updated June 4, 2025

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

  • Drug facts Active Ingredient  Purpose

    Capsaicin 0.075%.............................................Topical Analgesic

  • PURPOSE

  • 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 the skin.

    Do not use

    • on wounds or damaged skin
    • if you are allergic to capsaicum 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 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 doctor if

    • condition worsens or does not improve after regular use
    • severe burning persists or blistering occurs
  • DOSAGE & ADMINISTRATION

    Directions adults and children 18 years and older:

    • apply a thin film of cream to the 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

  • ASK DOCTOR

  • Other information

    Store at 20° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). See USP Controlled Room Temperature.

  • Inactive Ingredients

    aloe barbadensis leaf juice, cetyl alcohol, glyceryl stearate, mineral oil, PEG-100 stearate, peppermint oil, petrolatum, phenoxyethanol, propylene glycol, stearyl alcohol, water, xanthan gum

  • KEEP OUT OF REACH OF CHILDREN

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

  • SPL UNCLASSIFIED SECTION

    Questions? Call 877-227-3137

  • PRINCIPAL DISPLAY PANEL

    Capsaicin 0.075% Cream - NDC 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Tube Label

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    Capsaicin 0.075% Cream - NDC 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Carton Label

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    Manufactured For:

    ViolaCare, Inc.

    Parsippany, New Jersey, 07054

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 0.075% CREAM 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85231-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.075 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85231-202-601 in 1 CARTON06/02/2025
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/02/2025
    Labeler - ViolaCare, Inc. (119452160)