Label: WALGREENS CAPSAICIN HOT - capsaicin patch 

  • 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 06/13

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                                   Purpose

    Capsaicin extract 0.025% as Capsaicin.....................................Topical Analgesic

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  • PURPOSE

    Uses Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises
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  • WARNINGS

    Warnings

    • For external use only
    • Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower
    • Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use.
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding consult a healthcare professional before use.

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  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with, or at the same time as, other external analgesic products
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  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes or rashes
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  • STOP USE

    Stop use and ask a doctor if

    • conditions worsens
    • symptoms persist more than 7 days or clear up and occur again within a few days
    • rash, itching or excessive skin irritation develops
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  • 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.

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  • INDICATIONS & USAGE

    Directions

    • Adults and children 12 years of age and older:
    • clean and dry affected area
    • remove patch from film
    • apply to affected area no more than 3 to 4 times daily for 7 days
    • remove patch from the skin after at most 8 hours application
    • Children under 12 years of age: consult a doctor
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  • STORAGE AND HANDLING

    Other information

    • avoid storing product in direct sunlight
    • protect product from excessive moisture
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  • INACTIVE INGREDIENT

    Inactive ingredients BHT, Ester gum, isopropyl myristate, natural rubber, polybutene, polysobutylene, precipitated calcium carbonate, propylene carbonate, quinton, sorbitan monostearate, titanium dioxide, YS resin, Zinc oxide

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  • DOSAGE & ADMINISTRATION

    Distributed By:

    Walgreen Co

    200 Wilmot Rd.

    Deerfield, IL 60005

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    WALGREENS CAPSAICIN HOT 
    capsaicin extract patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-9113
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (CAPSAICIN) CAPSAICIN 0.6 mg
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLATED HYDROXYTOLUENE  
    ISOPROPYL MYRISTATE  
    NATURAL LATEX RUBBER  
    POLYBUTENE (1400 MW)  
    PROPYLENE CARBONATE  
    SORBITAN MONOSTEARATE  
    TITANIUM DIOXIDE  
    ZINC OXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-9113-03 3 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/30/2013
    Labeler - Walgreen Co (008965063)
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