Label: EXTRA STRENGTH COLD AND HOT MENTHOL PATCH- 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 January 11, 2023

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  • 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 not finalpart34803/01/2021
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech529128763manufacture(11822-6513)
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