Label: RAPID RELIEF HOT RELIEF PATCH- methyl salicylate patch

  • NDC Code(s): 83569-003-01
  • Packager: RAPID AID VIET NAM CO., LTD
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 6, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient(s)

    Methyl Salicylate 10% w/w.

  • Purpose

    Topical analgesic

  • Use

    For the temporary relief of minor aches and pains of muscles and joints associated with backache, lumbago, strains, buries, sprains and arthritis or rheumatic pain, or pain of tendons and ligaments.

  • Warnings

    For external use only.
    Do not apply to sensitive skin or open wounds.
    Avoid contact with eyes or mucous membranes
    If excessive redness, burning or discomfort of the skin develop, discontinue use and consult a healthcare practitioner.
    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a healthcare practitioner.
    Never use this product with any other heating or cooling device or with other external analgesic products.
    The application of external heat, such as an electric heating pad, may result in excessive skin irritation or burn.
    Do not bandage this product or cover with anything other than light clothing
    Do not use this product if you are allergic to salicylates or if you are taking anticoagulant medications.

  • Do not use

    on wounds, cuts, damaged or infected skin
    On eyes, mouth, genitals, or any other mucous membranes

  • When using this product:

    You may experience a burning sensation. The intensity of this reaction varies among individuals and may be sever. With regular use, this sensation generally disappears after several days.
    Avoid contact with the eyes, lips, nose and mucous membranes
    Do not tightly wrap or bandage the treated area
    Do not apply heat to the treated area immediately before or after use

  • Stop use and ask a doctor if:

    Allergic reaction occurs
    Condition worsens or does not improve within 7 days
    Symptoms clear up and return within a few days
    Redness, irritation, swelling, pain or other symptoms begin or increase

  • KEEP OUT OF REACH OF CHILDREN

    Children 12 years of age and under: should only use this product upon the advice of a healthcare practitioner.

  • Directions

    For use by adults and children 12 years of age and older:
    Open resealable pouch and remove patch
    If desired, cut patch to size
    Peel off protective film and apply sticky side to desired area
    Apply patch to affected area not more than 3 to 4 times daily and for no longer than 1-2 hours per application
    Remove patch before applying a new one
    Dispose of patch in waste receptacle after use

  • STORAGE AND HANDLING

    Store between 15-30℃(59-86℉) keep away from children

  • Inactive ingredients

    castor oil, dihydroxyaluminum aminoacetate, edetate disodium, gelatin, glycerine, menthol. Polyacrylic acid, polysorbate 80, polyvinyl alcohol, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric acid, water

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    RAPID RELIEF HOT RELIEF PATCH 
    methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83569-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    menthol (UNII: L7T10EIP3A)  
    castor oil (UNII: D5340Y2I9G)  
    gelatin (UNII: 2G86QN327L)  
    tartaric acid (UNII: W4888I119H)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    edetate disodium (UNII: 7FLD91C86K)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    dihydroxyaluminum aminoacetate (UNII: DO250MG0W6)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83569-003-011 in 1 BOX03/06/2024
    16 in 1 POUCH
    110 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/06/2024
    Labeler - RAPID AID VIET NAM CO., LTD (673067008)
    Registrant - RAPID AID VIET NAM CO., LTD (673067008)
    Establishment
    NameAddressID/FEIBusiness Operations
    RAPID AID VIET NAM CO., LTD673067008manufacture(83569-003)