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

  • NDC Code(s): 66403-308-23, 66403-308-25, 66403-308-35
  • Packager: Tiger Balm (Malaysia) Sdn. Bhd.
  • 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 December 12, 2019

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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 to 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 stains, 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.

  • Questions/Comments

    (510) 887-1899

  • PRINCIPAL DISPLAY PANEL - 18 g Carton

    NDC 66403-308-35

    TIGER BALM®

    RED EXTRA STRENGTH

    "WORKS WHERE IT HURTS"

    PAIN RELIEVING OINTMENT

    CONCENTRATED

    Principal Display Panel - 18 g Carton
  • INGREDIENTS AND APPEARANCE
    TIGER BALM RED   EXTRA STRENGTH
    camphor (synthetic) and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66403-308
    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:66403-308-251 in 1 BOX01/25/2002
    118 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:66403-308-351 in 1 BOX01/25/2002
    218 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:66403-308-231 in 1 BOX01/25/2002
    34 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/25/2002
    Labeler - Tiger Balm (Malaysia) Sdn. Bhd. (652104126)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tiger Balm (Malaysia) Sdn. Bhd.652104126MANUFACTURE(66403-308)
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