Label: TIGER BALM ACTIVE MUSCLE- methyl salicylate and menthol, unspecified form gel

  • NDC Code(s): 66761-128-02, 66761-128-60
  • Packager: Haw Par Healthcare Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 3, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Methyl Salicylate 16%Topical Analgesic
    Menthol 8%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

    Carbomer 940, Citric Acid Monohydrate, FD&C Blue No. 1, Fragrance Active Fresh 1, Methylated Spirit, PEG-15 Cocamine, PPG-5 Ceteth-20, Propylene Glycol, Purified Water.

  • Questions

    (925) 292-3888

  • PRINCIPAL DISPLAY PANEL - 60 G Tube Box

    TIGER BALM®

    NDC 66761-128-60

    ACTIVE

    MUSCLE
    GEL

    • COOLING RELIEF
    • MILDLY-SCENTED
    • NON-STICKY PAIN RELIEF GEL

    NET WT. 2 OZ. (60G)

    PRINCIPAL DISPLAY PANEL - 60 G Tube Box
  • INGREDIENTS AND APPEARANCE
    TIGER BALM   ACTIVE MUSCLE
    methyl salicylate and menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66761-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE160 mg  in 1 g
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    PEG-15 COCAMINE (UNII: 8L6LB12TSJ)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66761-128-601 in 1 BOX05/01/2018
    160 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:66761-128-022 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 DrugM01705/01/2018
    Labeler - Haw Par Healthcare Ltd. (659207039)
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