KWAN LOONG (METHYL SALICYLATE AND MENTHOL) OIL [HAW PAR HEALTHCARE LTD.]

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KWAN LOONG (METHYL SALICYLATE AND MENTHOL) OIL [HAW PAR HEALTHCARE LTD.]
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NDC 66761-311-01, 66761-311-22
Set ID 54bcb26e-786a-403e-9330-11ae9e3c013a
Category HUMAN OTC DRUG LABEL
Packager Haw Par Healthcare Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Methyl Salicylate 35%External Analgesic
    Menthol 16%External Analgesic
  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, bruises, sprain and strains.

  • Warnings

    FOR EXTERNAL USE ONLY.

    When using this product

    • Use only as directed
    • Avoid contact with eyes and mucous membranes
    • Do not apply to open wounds, damaged or irritated skin
    • Do not bandage or cover with any type of wrap except clothing
    • Do not use with heating pad or apply external heat
    • Do not use 1 hour prior to bathing or within 30 minutes after bathing.

    Stop use and ask a doctor if

    • Condition worsens
    • Pain persists for more than seven days
    • Pain clears up and then recurs a few days later
    • Severe skin irritation occurs.

    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

    • Adults and children 12 years of age or older, apply to the affected areas not more than 3 to 4 times daily
    • For children under 12 years old consult a doctor before use.
  • Other Information

    This product may cause allergic reaction on some individuals. Test on small area before use.

  • Inactive Ingredients

    Eucalyptus Oil, Spike Lavender Oil, Light Mineral Oil.

  • Questions

    (925) 292-3888

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    Haw Par Healthcare Ltd.,
    Singapore

  • PRINCIPAL DISPLAY PANEL - 57 ml Bottle Box

    NDC 66761-311-22

    KWAN
    LOONG    ®

    PAIN RELIEVING OIL

    For temporary relief of
    minor aches and pains of
    muscles and joints
    associated with simple
    backaches, arthritis, bruises,
    sprain and strains.

    2 Fl. Oz.
    (57ml)

    PRINCIPAL DISPLAY PANEL - 57 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    KWAN LOONG 
    methyl salicylate and menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66761-311
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Methyl salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ) Methyl salicylate350 mg  in 1 mL
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Spike Lavender Oil (UNII: 7S2HYV1VJQ)  
    Light Mineral Oil (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66761-311-011 in 1 BOX09/01/2005
    128 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:66761-311-221 in 1 BOX09/01/2005
    257 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2005
    Labeler - Haw Par Healthcare Ltd. (659207039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Haw Par Healthcare Ltd.659207039MANUFACTURE(66761-311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tiger Balm (Malaysia) Sdn. Bhd.652104126MANUFACTURE(66761-311)
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