Label: EXTRA STRENGTH COLD AND HOT MENTHOL PATCH- menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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

  • Active Ingredients

    Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

  • Uses

    Temporarily relieves minor pain.

  • Warnings

    For external use only.

  • When using this product

    ■ use only as directed

    ■ rear cases of serious burns have been reported with products of this type

    ■ Don't bandage tightly or use with a heating pad

    ■ Avoid contact with the eyes and mucous membranes

    ■Don't apply to wounds or damaged skin

    ■ Do not use at the same time as other topical analgesics

  • Stop use and consult a doctor

    ■ condition worsens

    ■ redness is present

    ■ irritation develops

    ■ symptoms persist for more than 7 days or clear up and occur again within a few days

    ■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • Keep out of reach of children and pets.

    If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

  • Dosage and Administration

    Directions Adults and children 12 years of age and over :

    ■ Carefully remove backing from patch

    ■ Apply sticky side of patch to affected area.

    ■ Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily..

    ■ Discard patch after single use.

    ■Reseal pouch after opening.

    ■Children under 12 years of age: consult a physician.

  • Other Safety Information

    Store at room temperature, not to exceed 86F (30C)

  • Inactive Ingredients

    Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerin, iodopropynyl butylcarbamate, Kaolin, mineral oil, petrolatum, Phenoxyethanol, polyacrylic acid, Polysorbate 80, Povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol

  • Uses

    Temporarily relieves minor pain.

  • Extra Strength Cold & Hot Menthol Patch

    label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH COLD AND HOT MENTHOL PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6513
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-6513-15 in 1 CARTON03/01/2021
    11 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2021
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech529128763manufacture(11822-6513)