Label: RAPID RELIEF PAIN RELIEF PATCH- lidocaine patch

  • NDC Code(s): 83569-002-01
  • Packager: RAPID AID VIET NAM CO., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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  • Active Ingredient(s)

    Lidocaine 4 % w/w.

  • Purpose

    Topical analgesic

  • Use

    Temporary relief of minor pain.

  • Warnings

    For external use only.

  • Do not use

     More than 1 patch at a time
     On wounds or damaged skin
     With a heating pad
     If you are allergic to any ingredients of this product

  • When using this product:

     Use only as directed
     Do not bandage tightly
     Avoid contact with eyes, mucous membranes or rashes

  • Stop use and ask a doctor if:

     Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
     Condition worsens
     Symptoms persist for more than 7 days
     Symptoms clear up and occur again within a few days

    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 right away.

  • Directions

    Adults and children 12 years of age and older:
     Clean and dry affected area
     Remove film from patch and apply to the skin
     Apply 1 patch at a time to the affected area, not more than 3 to 4 times daily.
     Remove patch from the skin after at most 8-hour application.
    Children under 12 years of age: consult a doctor

  • STORAGE AND HANDLING

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

  • Inactive ingredients

    Acyclovir, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetic acid, Glycerin, Polyacrylic acid, Sodium polyacrylate, Sodium Acryloyldimethyltaurate-acrylamide copolymer, Tartaric acid, Titanium dioxide, Wate

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    RAPID RELIEF PAIN RELIEF PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83569-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Acyclovir (UNII: X4HES1O11F)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    Dihydroxyaluminum aminoacetate (UNII: DO250MG0W6)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    DMDM hydantoin (UNII: BYR0546TOW)  
    Edetic acid (UNII: 9G34HU7RV0)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    Tartaric acid (UNII: W4888I119H)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83569-002-011 in 1 BOX03/06/2024
    16 in 1 POUCH
    14 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(83569-002)
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