CVS MEDICATED HEAT (CAPSICUM EXTRACT) PATCH [CVS PHARMACY]

CVS MEDICATED HEAT (CAPSICUM EXTRACT) PATCH [CVS PHARMACY]
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NDC 69842-091-03
Set ID 81cd1019-93a6-311b-e053-2991aa0a7997
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Capsicum extract 0.025% as Capsaicin.....................Topical analgesic

  • PURPOSE

    Uses

    temporarily relieves minor pain of muscles and joints 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
    • if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
  • DO NOT USE

    Do not use

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

    When using this product

    • do not use otherwise than directed
    • 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

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

    If pregnant or breast-feeding, ask a health 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

    Inactive ingredients

    lanolin, methyl salicylate, natural rubber, peppermint oil, petrolatum, rosin, zinc oxide

  • DOSAGE & ADMINISTRATION

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL

    60709

  • INGREDIENTS AND APPEARANCE
    CVS MEDICATED HEAT 
    capsicum extract patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM0.025 mg
    Inactive Ingredients
    Ingredient NameStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ROSIN (UNII: 88S87KL877)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-091-033 in 1 POUCH02/13/2019
    11 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/13/2019
    Labeler - CVS Pharmacy (062312574)

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