Label: TIGER BALM ARTHRITIS RUB (camphor- synthetic and menthol cream

  • NDC Code(s): 62003-422-02, 62003-422-04
  • Packager: Prince of Peace Enterprises, Inc.
  • 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 June 10, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Camphor 11%Topical Analgesic
    Menthol 11%Topical Analgesic
  • Uses

    For the temporary relief of minor aches and pains associated with arthritis, backache, stiffness, muscle 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 within 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

    • Shake well before using
    • Apply generously to affected areas and massage gently until cream is absorbed into the skin
    • 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 on some individuals. Test on small area before use
    • As part of its warming action, temporary redness may occur.
  • Inactive Ingredients

    Cajuput Oil, Chondroitin Sulfate, Cinnamon Oil, Clove Oil, Deionized Water, Dementholised Mint Oil, Diazolidinyl Urea, Glucosamine Sulfate, Methyl Paraben, Methylsulfonylmethane (MSM), PEG-120 Methyl Glucose Dioleate, Propyl Paraben, Propylene Glycol.

  • Questions/Comments

    (510) 887-1899

  • SPL UNCLASSIFIED SECTION

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

    Exclusive U.S. Distributor:
    Prince of Peace Ent., Inc.,
    751 N. Canyons Parkway, Livermore,
    CA 94551 USA.

  • PRINCIPAL DISPLAY PANEL - 113mL Bottle Carton

    NDC 62003-422-04

    TIGER BALM®

    Easy to use pump

    TIGER BALM®
    ARTHRITIS RUB

    Effective
    Arthritis Pain
    Relieving Cream

    Containing:
    Camphor, Menthol

    Alcohol-Free

    NET 4 Fl Oz (113mL)

    PRINCIPAL DISPLAY PANEL - 113mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TIGER BALM   ARTHRITIS RUB
    camphor (synthetic) and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62003-422
    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 mL
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form110 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cajuput Oil (UNII: J3TO6BUQ37)  
    Chondroitin Sulfate (Bovine) (UNII: 6IC1M3OG5Z)  
    Cinnamon Oil (UNII: E5GY4I6YCZ)  
    Clove Oil (UNII: 578389D6D0)  
    Water (UNII: 059QF0KO0R)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Glucosamine Sulfate (UNII: 1FW7WLR731)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    PEG-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62003-422-041 in 1 CARTON06/10/200202/28/2026
    1113 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:62003-422-022 mL in 1 PACKET; Type 0: Not a Combination Product06/10/200202/28/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Not Finalpart34806/10/200202/28/2026
    Labeler - Prince of Peace Enterprises, Inc. (131132714)
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