Label: TIGER BALM- camphor (synthetic) and menthol patch 

  • Label RSS
  • NDC Code(s): 66761-321-04
  • Packager: Haw Par Healthcare Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    Camphor 230mg / patch Topical Analgesic
    Menthol 70mg / patch Topical Analgesic
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  • Uses

    For temporary relief of pains.

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  • 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 30 minutes after bathing

    Stop use and ask a doctor if

    • Condition worsens
    • Severe skin irritation occurs
    • Pain persists for more than 7 days

    If pregnant or breast-feeding, ask a healthcare professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

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  • Directions

    • Adults and children 12 years and over apply to 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
    • Reseal pouch containing unused patches
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  • Other Information

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

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  • Inactive Ingredients

    Capsicum Extract, Eucalyptus Oil, Glycerin, Mentha Oil, Polyacrylic Acid, Polysorbate 80, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitan Monooleate, Sorbitol, Tartaric Acid, Water.

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  • Questions/Comments

    (510) 887-1899

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 4 Patch Carton

    NDC 66761-321-04

    TIGER BALM®

    LARGE

    TIGER BALM®
    PAIN RELIEVING
    LARGE PATCH

    Advanced Hydrogel Patch Technology

    • Stretchable
    • Long Lasting
    • Convenient And Not Messy
    • It Works!

    4 PATCHES (8 x 4 inches each)

    Principal Display Panel - 4 Patch Carton
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  • INGREDIENTS AND APPEARANCE
    TIGER BALM 
    camphor (synthetic) and menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66761-321
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Camphor (Synthetic) (Camphor (Synthetic)) Camphor (Synthetic) 230 mg
    Menthol (Menthol) Menthol 70 mg
    Inactive Ingredients
    Ingredient Name Strength
    Eucalyptus Oil  
    Glycerin  
    Polysorbate 80  
    Carboxymethylcellulose Sodium  
    Sorbitan Monooleate  
    Sorbitol  
    Tartaric Acid  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66761-321-04 1 in 1 BOX
    1 4 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 01/15/2007
    Labeler - Haw Par Healthcare Ltd. (659207039)
    Establishment
    Name Address ID/FEI Business Operations
    Teh Seng Pharmaceutical Mfg. Co., Ltd. 656347721 MANUFACTURE(66761-321)
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