Label: CAPSAICIN- capsaicin cream

  • NDC Code(s): 50488-1025-1, 50488-1025-5
  • Packager: Alexso, Inc.
  • 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 February 13, 2019

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

  • Active ingredient

    Capsaicin 0.025%

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  • Purpose

    External analgesic

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  • Uses

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

    simple backache
    arthritis
    strains
    sprains
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  • 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

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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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

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  • Other Information

    Store at 20-25 oC (68-77 oF); excursion permitted to 15-30 oC (59-86 oF). See USP Controlled Room Temperature.
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  • Inactive ingredients

    Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

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  • PRINCIPAL DISPLAY PANEL – 120 GRAM TUBE

    NDC: 50488-1025-1
    Capsaicin 0.025% Cream
    120 grams

    Manufactured for: Alexso, Inc.
    2317 Cotner Avenue Los Angeles, CA 90064
    Tel: 888.495.6078

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    Label

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  • Principal Display Panel – 50 GRAM TUBE

    Capsaicin 0.025% Cream
    50 grams     NDC: 50488-1025-5

    Manufactured for: Alexso, Inc.
    2317 Cotner Avenue Los Angeles, CA 90064
    Tel: 888.495.6078

    image-02

    Label

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  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-1025
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50488-1025-1 1 in 1 CARTON 10/01/2018
    1 120 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:50488-1025-5 1 in 1 CARTON 10/01/2018
    2 50 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/01/2018
    Labeler - Alexso, Inc. (963338061)
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