Label: TIGER BALM NECK AND SHOULDER RUB (camphor- synthetic and menthol cream

  • NDC Code(s): 66761-341-01, 66761-341-03, 66761-341-50
  • Packager: Haw Par Healthcare Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Camphor 11%, Menthol 10%

  • Purpose

    Topical analgesics

  • Uses

    For temporary relief of minor aches and pains of neck and shoulder muscles and joints

  • 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 breastfeeding, 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, 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.

  • Inactive Ingredients

    Dementholised Mint Oil, Diazolidinyl Urea, Eucalyptus Oil, FD&C Blue 1, Glycerin, Lavender Fragrance, Methyl Glucose Dioleate, Methylparaben, PVM/MA Decadiene Crosspolymer, Propylene Glycol, Propylparaben, Triethanolamine (TEA), Water.

  • SPL UNCLASSIFIED SECTION

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

  • Questions/Comments

    (510) 887-1899

  • PRINCIPAL DISPLAY PANEL - 50g Tube Carton

    NDC 66761-341-50

    TIGER BALM®

    TIGER BALM®
    NECK &
    SHOULDER
    RUB

    Pain Relieving
    Cream

    Non-Greasy

    Soothing
    Relief

    VANISHING
    SCENT

    Soothing relief for stressed
    and strained muscles

    Net Wt. 1.76 oz (50g)

    Principal Display Panel - 50g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TIGER BALM   NECK AND SHOULDER RUB
    camphor (synthetic) and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66761-341
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)11 mg  in 1 g
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Eucalyptus oil (UNII: 2R04ONI662)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Glycerin (UNII: PDC6A3C0OX)  
    Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Trolamine (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66761-341-501 in 1 CARTON10/24/2008
    150 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:66761-341-011 in 1 CARTON10/24/2008
    25 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:66761-341-033 g in 1 PACKET; Type 0: Not a Combination Product10/24/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/24/2008
    Labeler - Haw Par Healthcare Ltd. (659207039)
    Establishment
    NameAddressID/FEIBusiness Operations
    OLIC (Thailand) Limited659673016MANUFACTURE(66761-341)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haw Par Healthcare Ltd.659207039MANUFACTURE(66761-341)
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