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
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 7, 2021

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

  • 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 NOT FINALpart34803/01/2021
    Labeler - Haw Par Healthcare Ltd. (659207039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haw Par Healthcare Ltd.659207039MANUFACTURE(66761-354)