Label: CVS MEDICATED HEAT 1 CT- capsaicin 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 April 9, 2021

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

  • 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)