Label: EXTRA STRENGTH COLD-HOT MEDICATED PATCHES- menthol patch

  • NDC Code(s): 70000-0367-1
  • Packager: Cardinal Health, 110 dba LEADER
  • 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 January 11, 2023

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

  • ACTIVE INGREDIENT

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

  • INACTIVE INGREDIENT

    CMC, Dihydroxy aluminum Aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 12 years of age and over: 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. Discard patch after single use. Children under 12 years of age: 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

    label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH COLD-HOT MEDICATED PATCHES 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0367
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0367-15 in 1 BOX01/01/2019
    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 finalpart34801/01/2019
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(70000-0367)