Label: RITE AID HOT AND COLD BACK 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 Ingredient

    Menthol 5%

  • Purpose

    Topical anesthetic

  • Use

    For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps

  • Warnings

    For external use only

  • When using this product

    ■Use only as directed ■ Rare cases of serious burns have been reported with products of this type ■Don't bandage tightly or use with heating pad ■ Avoid contact with 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 if

    o condition worsens

    o redness is present

    o irritation develops

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

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

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of reach of children and pets

    Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    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 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age: consult a physician.

  • Other information

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

  • Inactive Ingredient

    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

  • Rite Aid Hot and Cold Back Patch

    label

  • INGREDIENTS AND APPEARANCE
    RITE AID HOT AND COLD BACK PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9991
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TARTARIC ACID (UNII: W4888I119H)  
    POVIDONE (UNII: FZ989GH94E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    3-IODO-2-PROPYNOL (UNII: A477M4X26N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-9991-33 in 1 CARTON03/01/2023
    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 DrugM01703/01/2023
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.529128763manufacture(11822-9991)