Label: TIGER BALM RED EXTRA STRENGTH (camphor- synthetic and menthol ointment

  • NDC Code(s): 66761-308-23, 66761-308-25, 66761-308-35, 66761-308-40
  • 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
    Camphor 11%Topical Analgesic
    Menthol 10%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 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, rub well on the affected area. Repeat 3-4 times daily
    • For children 12 years of age or younger, consult a doctor before use.
  • Other Information

    • This product may cause allergic reaction in some individuals. Test on small area before use
    • Tiger Balm Red Extra Strength may stain cloth items. To avoid possibility of strains, use Tiger Balm White Regular Strength or Tiger Balm Ultra Strength.
  • Inactive Ingredients

    Cajuput Oil, Cassia Oil, Clove Oil, Dementholised Mint Oil and Paraffin Petrolatum.

  • SPL UNCLASSIFIED SECTION

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

  • Questions

    (510) 887-1899

  • PRINCIPAL DISPLAY PANEL - 18 G Jar Box

    NDC 66761-308-25

    TIGER BALM®

    RED EXTRA STRENGTH

    PAIN RELIEVING OINTMENT

    NET WT: 0.63 OZ (18G)

    Principal Display Panel - 18 G Jar Box
  • INGREDIENTS AND APPEARANCE
    TIGER BALM RED   EXTRA STRENGTH
    camphor (synthetic) and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66761-308
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)110 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Cajuput Oil (UNII: J3TO6BUQ37)  
    Chinese Cinnamon Oil (UNII: A4WO0626T5)  
    Clove Oil (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66761-308-231 in 1 BOX08/17/2005
    14 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:66761-308-251 in 1 BOX08/17/2005
    218 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:66761-308-351 in 1 BOX08/17/2005
    318 g in 1 JAR; Type 0: Not a Combination Product
    4NDC:66761-308-401 in 1 BOX03/01/2021
    44 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01708/17/2005
    Labeler - Haw Par Healthcare Ltd. (659207039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haw Par Healthcare Ltd.659207039MANUFACTURE(66761-308)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tiger Balm (Malaysia) Sdn.Bhd.652104126MANUFACTURE(66761-308)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Tiger Medical Company, Ltd.527257083MANUFACTURE(66761-308)
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