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

  • NDC Code(s): 66761-324-04
  • 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 26, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    DL-Camphor 230 mg/patchTopical Analgesic
    L-Menthol 70 mg /patchTopical Analgesic
    Capsicum Extract 46 mg/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 clear 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 Poison Control Center right away.

  • 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
  • Other Information

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

  • Inactive Ingredients

    Carboxymethylcellulose Sodium, Eucalyptus Oil, Glycerin, Mentha Oil, Methyl Acrylate and 2-Ethylhexyl Acrylate Copolymer, Purified Water, Polysorbate 80, PVA Solution, Silicon Dioxide, Sodium Polyacrylate, Sodium Polyacrylate Starch, Sorbitan Monooleate, Sorbitol Solution, Tartaric Acid

  • Questions/Comments

    (925) 292-3888

  • PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Label

    NDC 66761-324-04

    LARGE

    TIGER BALM®

    TIGER BALM®
    PAIN RELIEVING
    HYDROGEL PATCH

    Advanced Hydrogel Patch Technology

    For temporary relief of pains

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

    4 PATCHES (8 x 4 inches each)

    PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Label
  • INGREDIENTS AND APPEARANCE
    TIGER BALM PAIN RELIEVING HYDROGEL   LARGE
    camphor (synthetic), levomenthol, and capsicum patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66761-324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)230 mg
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL70 mg
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM46 mg
    Inactive Ingredients
    Ingredient NameStrength
    carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)  
    eucalyptus oil (UNII: 2R04ONI662)  
    glycerin (UNII: PDC6A3C0OX)  
    methyl acrylate (UNII: WC487PR91H)  
    water (UNII: 059QF0KO0R)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sorbitan monooleate (UNII: 06XEA2VD56)  
    sorbitol (UNII: 506T60A25R)  
    tartaric acid (UNII: W4888I119H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66761-324-041 in 1 BOX01/01/2017
    14 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2017
    Labeler - Haw Par Healthcare Ltd. (659207039)