WALGREENS CAPSAICIN HOT (CAPSAICIN EXTRACT) PATCH [WALGREEN CO]

WALGREENS CAPSAICIN HOT (CAPSAICIN EXTRACT) PATCH [WALGREEN CO]
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NDC 0363-9113-03
Set ID 6a44d76e-72d7-41b8-9d66-7f1251b34a05
Category HUMAN OTC DRUG LABEL
Packager Walgreen Co
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient                                                                                   Purpose

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

  • PURPOSE

    Uses Temporarily relieves minor pain associated with:

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

    Warnings

    • For external use only
    • Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.
  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
  • WHEN USING

    When using this product

    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower
  • 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
    • redness is present or irritation or rash develops
    • a severe burining sensation occurs
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • 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
    • do not wear patch for more than 8 hours
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

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

    butylhydroxytoluene, glyceryl rosinate, isopropyl myristate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (ys resin), titanium dioxide, zinc oxide

  • QUESTIONS

    Questions or comments?

    Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Walgreen Co

    200 Wilmot Rd.

    Deerfield, IL 60005

    Made in South Korea

  • PRINCIPAL DISPLAY PANEL

    541902

  • INGREDIENTS AND APPEARANCE
    WALGREENS CAPSAICIN HOT 
    capsaicin extract patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    GLYCERYL ROSINATE (UNII: SD112V492J)  
    POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9113-033 in 1 POUCH; Type 0: Not a Combination Product12/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2013
    Labeler - Walgreen Co (008965063)

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