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

  • NDC Code(s): 66761-341-01, 66761-341-50
  • 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 Ingredients

    Camphor 11%, Menthol 10%

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  • Purpose

    Topical analgesics

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  • Uses

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

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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 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.

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  • 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.
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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

    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.

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  • SPL UNCLASSIFIED SECTION

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

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  • Questions/Comments

    (510) 887-1899

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  • PRINCIPAL DISPLAY PANEL - 50g Carton

    NDC 66761-341-50

    TIGER BALM®

    TIGER BALM®
    NECK &
    SHOULDER
    RUB

    Pain Relieving
    Cream

    Non-Greasy

    Fast Relief

    VANISHING
    SCENT

    Fast relief for stressed
    and strained muscles

    Net Wt. 1.76 oz (50g)

    Principal Display Panel - 50g Carton
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  • INGREDIENTS AND APPEARANCE
    TIGER BALM   NECK AND SHOULDER RUB
    camphor (synthetic) and menthol cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66761-341
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Camphor (Synthetic) (Camphor (Synthetic)) Camphor (Synthetic) 11 mg  in 1 g
    Menthol (Menthol) Menthol 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Diazolidinyl Urea  
    Eucalyptus oil  
    FD&C Blue No. 1  
    Glycerin  
    Peg-120 Methyl Glucose Dioleate  
    Methylparaben  
    Propylene Glycol  
    Propylparaben  
    Trolamine  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66761-341-50 1 in 1 CARTON
    1 50 g in 1 TUBE
    2 NDC:66761-341-01 1 in 1 CARTON
    2 5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 10/24/2008
    Labeler - Haw Par Healthcare Ltd. (659207039)
    Establishment
    Name Address ID/FEI Business Operations
    Drug Houses of Austrailia Asia PTE LTD 595132739 MANUFACTURE(66761-341)
    Establishment
    Name Address ID/FEI Business Operations
    OLIC (Thailand) Limited 659673016 MANUFACTURE(66761-341)
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