Label: CVS CAPSAICIN  - capsaicin cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                      Purpose

    Capsaicin 0.1%........................................................................Topical analgesic

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  • PURPOSE

    For the temporary relief of minor pain associated with:

    • Arthritis
    • Simple backache
    • Muscle strains
    • Sprains
    • Bruises
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  • WARNINGS

    Warnings

    For external use only

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  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage
    • do not use with heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds, damaged, broken or irritated skin
    • a slight burning
    • sensation may occur upon application but generally disappears in several days
    • if severe burning occurs, discontinue use
    • do not expose the treated area to heat or direct sunlight
    • do not use if allergic to capsicum or chili peppers
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  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • irritation develops
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS & USAGE

    Directions

    Adults and children over 18 years:

    • apply generously to affected area not more than 3 to 4 times daily
    • massage into painful area until thoroughly absorbed
    • wash hands with soap and water after use
    • close cap tightly after use
    Children 18 years or younger: Ask a doctor
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  • INACTIVE INGREDIENT

    Inactive ingredients

    Benzyl alcohol, cetyl alcohol, citric acid, glyceryl stearate SE, isopropyl myristate, PEG 100 stearate, petrolatum, purified water, sorbitol

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  • DOSAGE & ADMINISTRATION

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    www.cvs.com

    Made in Korea

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  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • Lot No. and Exp. Date: see box or crimp of tube
    • save carton for complete Drug Facts information
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  • INGREDIENTS AND APPEARANCE
    CVS CAPSAICIN  
    capsaicin cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-381
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (CAPSAICIN) CAPSAICIN 0.1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL  
    CETYL ALCOHOL  
    CITRIC ACID MONOHYDRATE  
    GLYCERYL MONOSTEARATE  
    ISOPROPYL MYRISTATE  
    PEG-100 STEARATE  
    PETROLATUM  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-381-42 1 in 1 CARTON
    1 42 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/31/2013
    Labeler - CVS PHARMACY (062312574)
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