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WHITE FLOWER ANALGESIC BALM (HOE HIN PAK FAH YEOW MANUFACTORY LTD)

Available Formats

Dosage Form Package Information Links
OIL 10 mL in 1 BOTTLE, GLASS (48256-0002-2) Label Information
OIL 20 mL in 1 BOTTLE, GLASS (48256-0002-1) Label Information
OIL 5 mL in 1 BOTTLE, GLASS (48256-0002-3) Label Information
OIL 2.5 mL in 1 BOTTLE, GLASS (48256-0002-4) Label Information

Complete WHITE FLOWER ANALGESIC BALM Information

  • ACTIVE INGREDIENT

    Active ingredients

    Camphor 6%

    Menthol 15%

    Methyl salicylate 40%


  • PURPOSE

    Purpose

    External analgesic



  • DO NOT USE


    Do not use

    • on wounds
    • on irritated or damaged skin
    • on the face
    • otherwise than as directed

  • WHEN USING

    When using this product

    • avoid contact with the eyes or mucous membranes
    • do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive irritation of the skin develops
    • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
    • when using for pain of arthritis
      • pain persists for more than 10 days
      • redness is present
      • in conditions affecting children under 12 years of age

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning

    If swallowed, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 3 years of age and older: Apply a few drops then gently rub into the affected area not more than 3 to 4 times daily.
    • Children under 3 years of age: Do not use, consult your doctor.
    • Refer to the above warnings; use otherwise than as directed may be dangerous.

  • STORAGE AND HANDLING

    Other information

    • keep container tightly closed
    • store at 15º to 30ºC (59º to 86ºF)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Eucalyptus oil, lavender oil and peppermint oil.


  • QUESTIONS

    Questions or comments? (888)221-3496 M-F 9am to 5pm

    • you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    WHITE FLOWER ANALGESIC BALM  NDC-48256-0002-1  0.67 fl oz (20mL)IMAGE OF CARTON 20ML


  • INDICATIONS & USAGE

    Uses  For the temporary relief of minor aches and pains of muscles and joints due to

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains

  • WARNINGS

    Warnings

    For external use only


  • INGREDIENTS AND APPEARANCE
    WHITE FLOWER ANALGESIC BALM 
    camphor, menthol and methyl salicylate oil
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:48256-0002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 6.0 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 14.5 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 40.02 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:48256-0002-1 20 mL in 1 BOTTLE, GLASS
    2 NDC:48256-0002-2 10 mL in 1 BOTTLE, GLASS
    3 NDC:48256-0002-4 2.5 mL in 1 BOTTLE, GLASS
    4 NDC:48256-0002-3 5 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/11/2010
    Labeler - HOE HIN PAK FAH YEOW MANUFACTORY LTD (686359001)
    Establishment
    Name Address ID/FEI Business Operations
    HOE HIN PAK FAH YEOW MANUFACTORY LTD 686359001 manufacture(48256-0002)
    Establishment
    Name Address ID/FEI Business Operations
    MACAU-UNION PHARMACEUTICAL LTD 448605614 repack(48256-0002)