PAIN RELIEVING PATCH ULTRA STRENGTH ULTRA STRENGTH (MENTHOL) PATCH [CVS PHARMACY, INC.]

PAIN RELIEVING PATCH ULTRA STRENGTH ULTRA STRENGTH (MENTHOL) PATCH [CVS PHARMACY, INC.]
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NDC 59779-991-01
Set ID 189c313d-f0a3-4593-852e-addbe9082524
Category HUMAN OTC DRUG LABEL
Packager CVS PHARMACY, INC.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredient
    Menthol 5%

  • PURPOSE

    Purpose

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves minor aches and pains of muscles and joints associated with:

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

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions
  • ASK DOCTOR

    Ask a doctor before use if you

    • have redness over the affected area
    • are pregnant or breastfeeding
  • WHEN USING

    When using this product

    • avoid contact with eyes and mucous membranes
    • do not bandage tightly
    • do not use with a heating pad or other heating device
  • STOP USE

    Stop using this product if

    • condition worsens
    • excessive skin irritation occurs
    • redness is present
    • symptoms persist more than 7 days or clear up and occur again within a few days
    If pregnant or breastfeeding consult 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 right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • open pouch and remove patch
    • if desired, cut patch to size
    • peel off protective backing and apply sticky side to affected area
    • adults and children 12 years of age and older apply to affected area no more than 3 to 4 times daily
    • children under 12 years of age consult a doctor
    • For best results, please ensure that the skin is clean and dry before applying
    • reseal pouch
  • INACTIVE INGREDIENT

    Inactive Ingredients BHT, castor oil, cellulose gum, disodium edetate, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, PEG-4 stearate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, titanium dioxide. Release Liner: polyethylene, Non-Woven Material: polyester non-woven fabric.

  • QUESTIONS

    Questions? Call toll-free 1-800-645-3867

  • PRINCIPAL DISPLAY PANEL


    Image of box label

    Image of pouch label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING PATCH ULTRA STRENGTH   ULTRA STRENGTH
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-991
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Silodrate (UNII: 9T3UU8T0QK)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Castor Oil (UNII: D5340Y2I9G)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Kaolin (UNII: 24H4NWX5CO)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Peg-4 Stearate (UNII: J33E8608YN)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Polyvinyl Alcohol (UNII: 532B59J990)  
    Water (UNII: 059QF0KO0R)  
    Tartaric Acid (UNII: W4888I119H)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-991-015 in 1 BOX
    11 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/15/2013
    Labeler - CVS PHARMACY, INC. (062312574)

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