Label: TIGER BALM PAIN RELIEVING HYDROGEL (camphor- synthetic, levomenthol, and capsicum patch

  • NDC Code(s): 66761-354-02
  • Packager: Haw Par Healthcare Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 16, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Camphor 160mg / patchTopical Analgesic
    Menthol 48mg / patchTopical Analgesic
    Capsicum Extract 32mg / patchTopical Analgesic
  • Uses

    For temporary relief of pains.

  • Warnings

    FOR EXTERNAL USE ONLY.

    When using this product

    • Use only as directed
    • Do not get into eyes or on mucous membranes
    • Do not apply to wounds, damaged or irritated skin
    • Do not bandage or cover with any type of wrap except clothing
    • Do not use with a heating pad or apply external heat
    • Do not use 1 hour prior to bathing or within 30 minutes after bathing.

    Stop use and ask a doctor if

    • Condition worsens
    • Severe skin irritation occurs
    • Pain persists for more than 7 days
    • Symptoms clears up and occur again within a few days

    If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare 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 and over apply to the affected area; change patch 1 to 2 times daily
    • Children under 12 years, consult doctor before use
    • How to apply:
      • Clean and dry affected area
      • Cut open pouch and remove patch
      • Remove protective film and apply directly to area of pain
      • Apply to affected area not more than 3 times daily
      • Wash hands with soap after applying patch
  • Other Information

    This product may cause allergic reaction on some individuals. Store in cool dry place away from direct sunlight.

  • Inactive Ingredients

    Aluminium glycinate, eucalyptus oil, glycerin, hydrotalcite, kaolin, mentha oil, polysorbate 80, polyacrylic acid solution, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, sorbitol solution, water

  • Questions/Comments

    (925) 292-3888

  • SPL UNCLASSIFIED SECTION

    Manufactured by Haw Par Healthcare Ltd.,
    Singapore under licence from Haw Par
    Corporation Ltd.

  • PRINCIPAL DISPLAY PANEL - 2 Patch Pouch

    2 PATCH PACK
    X WIDER SIZE*

    *As compared to our
    Regular Size Patch (4" x 2.75")

    NDC 66761-354-02

    TIGER BALM®

    TIGER BALM®
    PAIN RELIEVING
    PATCH

    Advanced Hydrogel Patch Technology

    For temporary relief of pains

    • Convenient And Not Messy
    • Works Where It Hurts
    • Long Lasting

    2 PATCHES (3.9 x 5.5 inches each)

    LOT:

    EXP:

    Principal Display Panel - 2 Patch Pouch
  • INGREDIENTS AND APPEARANCE
    TIGER BALM   PAIN RELIEVING HYDROGEL
    camphor (synthetic), levomenthol, and capsicum patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66761-354
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)160 mg
    Levomenthol (UNII: BZ1R15MTK7) (Levomenthol - UNII:BZ1R15MTK7) Levomenthol48 mg
    Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum32 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Glycerin (UNII: PDC6A3C0OX)  
    Kaolin (UNII: 24H4NWX5CO)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66761-354-022 in 1 POUCH; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01703/01/2021
    Labeler - Haw Par Healthcare Ltd. (659207039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haw Par Healthcare Ltd.659207039MANUFACTURE(66761-354)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tiger Balm (Malaysia) Sdn. Bhd.813058014MANUFACTURE(66761-354)
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