Label: WALGREENS CAPSAICIN HOT- capsaicin extract patch

  • 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 December 4, 2018

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  • 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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