Label: COLD AND HOT MEDICATED PAIN RELIEF SMALL- 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 September 12, 2011

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  • Active Ingredient

    Menthol 5%
  • Purpose

    Topical analgesic
  • Uses

    Temporarily relieves minor pain associated with:
    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • muscle sprains
    • bruises
    • cramps
  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    For use on children 12 years or younger consult a doctor. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children over 12 years:
    • carefully remove backing from patch
    • apply sticky side of patch to affected area
    • repeat as necessary, but no more than 4 times daily
  • Inactive ingredients

    2-ethylhexyl acrylate, acrylic acid, aluminium hydroxide, carboxymethylcellulose sodium, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate, sorbitan sesquioleate, starch, talc, tartaric acid, titanium oxide

  • package label


    Best Choice Cold and Hot Small Medicated Patch
    image of carton label
  • INGREDIENTS AND APPEARANCE
    COLD AND HOT MEDICATED PAIN RELIEF SMALL 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-950
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL ACRYLATE (UNII: WC487PR91H)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-950-051 in 1 CARTON
    15 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/12/2011
    Labeler - Valu Merchandisers Company, Inc. (868703513)
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