CVS MEDICATED HEAT 1 CT (CAPSAICIN) PATCH [CVS PHARMACY, INC.]

CVS MEDICATED HEAT 1 CT (CAPSAICIN) PATCH [CVS PHARMACY, INC.]
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NDC 59779-770-01
Set ID d41dce5b-e698-4930-8869-040b2a973f25
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Capsicum Extract 0.025% as Capsaicin ................. Topical Analgesic

  • PURPOSE

    Uses

    For temporary relief of minor aches and pains of muscles & joints associated with:

    • Simple backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains
  • 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 as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly
    • discontinue use at least 1 hour before a beath or shower
    • do not use immediately after a bath or shower
  • ASK DOCTOR

    Stop use and ask a doctor if:

    • conditions 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 Poision Control Center right away

  • INDICATIONS & USAGE

    Directions

    Adults and Children 12 years of age and over:

    • Clean and dry affected area
    • Remove patch from film
    • Apply to affected area not 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 ingredietns

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

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    CVS Pharmacy, Inc.

    Woonsocket, RI 02895

    Made in China

  • PRINCIPAL DISPLAY PANEL

    12129

  • INGREDIENTS AND APPEARANCE
    CVS MEDICATED HEAT 1 CT 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-770
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ROSIN (UNII: 88S87KL877)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-770-011 g in 1 POUCH; Type 0: Not a Combination Product09/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/16/2014
    Labeler - CVS Pharmacy, Inc. (062312574)

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