Label: COLD-HOT MEDICATED PATCHES- 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 1, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredient ...............................................................................................Purpose
    Menthol 5%...............................................................................................Topical Analgesic

  • INACTIVE INGREDIENT

    Glycerin, Sodium Polyacrylate, Water, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium
    Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control

  • INDICATIONS & USAGE

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

  • WARNINGS

    For External Use Only.

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

    Wear one patch up to 8 hours. Repeat as necessary, but no more than 4 times daily. Reseal pouch after opening.

    Children 12 years or younger: Consult a physician.

  • PURPOSE

    Topical Analgesic

  • When using this product

    Use only as directed ■ Don’t bandage tightly or use with heating pad
    ■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.

  • Stop use and ask a doctor

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

  • If pregnant or breastfeeding

    ask a health professional before use.

  • PRINCIPAL DISPLAY PANEL

    Manufactured for:
    Veridian Healthcare
    Gurnee, IL 60031 USA

    Large Patch Label Image
  • INGREDIENTS AND APPEARANCE
    COLD-HOT MEDICATED PATCHES 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-952
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TARTARIC ACID (UNII: W4888I119H)  
    POVIDONES (UNII: FZ989GH94E)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-952-056 in 1 BOX10/01/2017
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2017
    Labeler - Shopko Stores Operating Co., LLC (023252638)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beijing HKKY Medical544434817manufacture(37012-952)