Label: RAPID RELIEF COLD RELIEF PATCH- menthol patch

  • NDC Code(s): 83569-001-01
  • Packager: RAPID AID VIET NAM CO., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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

  • Active Ingredient(s)

    Menthol 4.26% w/w

  • Purpose

    Topical analgesic

  • Use

    Temporary relief of minor pain.

  • Warnings

    For external use only.

  • Do not use

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

  • When using this product:

     Use only as directed
     Rear cases of serious burns have been reported with products of this type
     Do not bandage tightly or use with a heating pad
     Avoid contact with eyes and mucous membranes
     Do not apply to wounds or damaged skin.
     Do not use at the same time as other topical analgesics.

  • Stop use and ask a doctor if:

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    For use by adults and children 12 years of age and older:
     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.

  • STORAGE AND HANDLING

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

  • Inactive ingredients

    Glycerin, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Dihydroxyaluminum aminoacetate, DMDM hydantoin, Isopropyl myristate, Edetic acid, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    RAPID RELIEF COLD RELIEF PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83569-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol4.26 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    DMDM hydantoin (UNII: BYR0546TOW)  
    Edetic acid (UNII: 9G34HU7RV0)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Dihydroxyaluminum aminoacetate (UNII: DO250MG0W6)  
    Isopropyl myristate (UNII: 0RE8K4LNJS)  
    Tartaric acid (UNII: W4888I119H)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83569-001-011 in 1 BOX03/06/2024
    16 in 1 POUCH
    14.62 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(83569-001)