Label: PAIN RELIEVING PATCH ULTRA STRENGTH- menthol 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 October 4, 2013

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

  • 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
    If pregnant or breast-feeding, consult a healthcare professional before use

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • 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
  • 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 devices
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • excessive skin irritation occurs
    • redness is present
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • 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
  • STORAGE AND HANDLING

    Other information

    • store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    alumina magnesioum metasilicate, BHT, castor oil, cellulose gum, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polyacrylic acid, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate, tartaric acid, titanium dioxide.

  • QUESTIONS

    Questions or comments?

    1-800-WALGREENS (1-800-925-4733)

  • PRINCIPAL DISPLAY PANEL


    Image of box label

    Image of pouch label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING PATCH  ULTRA STRENGTH
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol.05 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:0363-0151-014 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 - Walgreen Co. (008965063)