Label: TIGER BALM- methyl salicylate and menthol liniment 

  • Label RSS
  • NDC Code(s): 66761-333-22
  • 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
    Oil of Wintergreen 28% Topical Analgesic
    Menthol 16% Topical Analgesic
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  • Uses

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

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  • 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 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 childern. If swallowed, get medical help or contact a Poison Control Center immediately.

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  • Directions

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

    This product may cause allergic reaction in some individuals. Test on small area before use.

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  • Inactive Ingredients

    Eucalyptus Oil, Spike Lavender Oil, Light Mineral Oil.

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  • Questions

    (510) 887-1899

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  • PRINCIPAL DISPLAY PANEL - 57ml Carton

    NDC 66761-333-22

    TIGER BALM®

    LINIMENT

    2 FL.OZ. 57ml

    Principal Display Panel - 57ml Carton
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  • INGREDIENTS AND APPEARANCE
    TIGER BALM 
    methyl salicylate and menthol liniment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66761-333
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Methyl Salicylate (Salicylic Acid) Methyl Salicylate 260.4 mg  in 1 mL
    Menthol (Menthol) Menthol 148.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Eucalyptus oil  
    spike lavender oil  
    light mineral oil  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66761-333-22 1 in 1 BOX
    1 57 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/08/2005
    Labeler - Haw Par Healthcare Ltd. (659207039)
    Registrant - Tiger Balm (Malaysia) Sdn. Bhd. (652104126)
    Establishment
    Name Address ID/FEI Business Operations
    Haw Par Healthcare Ltd. 659207039 MANUFACTURE(66761-333)
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