Label: TIGER BALM ACTIVE MUSCLE RUB (methyl salicylate, menthol, unspecified form, and camphor- synthetic cream

  • NDC Code(s): 66761-129-02, 66761-129-60
  • 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 March 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Methyl Salicylate 15%Topical Analgesic
    Menthol 5%Topical Analgesic
    Camphor 3%Topical Analgesic
  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains and sprains.

  • Warnings

    For external use only.

    When using this product

    • Use only as directed
    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds, damaged or irritated skin
    • Do not bandage or cover with wrap or use heating pad
    • 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
    • Pain clears up and then recurs a few days later.

    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 immediately.

  • Directions

    • For adults and children over 12 years of age, rub well on the affected area. Repeat 3 to 4 times daily
    • For children 12 years of age or younger, consult a doctor before use.
  • Other Information

    • Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use
    • This product may cause allergic reaction on some individuals. Test on small area before use
    • Store at room temperature.
  • Inactive Ingredients

    Diazolidinyl Urea, Glycerin, Methyl Glucose Dioleate, Methyl Paraben, Poly (Methyl Vinyl Ether/Maleic Anhydride) Decadiene Crosspolymer, Propyl Paraben, Propylene Glycol, Purified Water, Triethanolamine.

  • Questions

    (925) 292-3888

  • PRINCIPAL DISPLAY PANEL - 60 G Tube Box

    TIGER BALM®

    NDC 66761-129-60

    ACTIVE

    MUSCLE
    RUB

    • PRE-SPORTS WARM-UP
    • RELIEF FOR SORE MUSCLES
    • NON-GREASY PAIN RELIEF
      CREAM

    NET WT. 2 OZ. (60G)

    PRINCIPAL DISPLAY PANEL - 60 G Tube Box
  • INGREDIENTS AND APPEARANCE
    TIGER BALM   ACTIVE MUSCLE RUB
    methyl salicylate, menthol, unspecified form, and camphor (synthetic) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66761-129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM50 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66761-129-601 in 1 BOX05/01/2018
    160 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:66761-129-022 g in 1 POUCH; Type 0: Not a Combination Product05/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34805/01/2018
    Labeler - Haw Par Healthcare Ltd. (659207039)
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