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

Available Formats

Dosage Form Package Information Links
OIL 10 mL in 1 BOTTLE, GLASS (48256-0011-1) Label Information
OIL 5 mL in 1 BOTTLE, GLASS (48256-0011-2) Label Information

Complete WHITE FLOWER ANALGESIC BALM FLORAL SCENTED Information

  • ACTIVE INGREDIENT

    Active ingredients

    Camphor 5.4%

    Menthol 13.1%

    Methyl salicylate 36%


  • PURPOSE

    Purpose

    External analgesic


  • DO NOT USE

    Do not use

    • on irritated or damaged skin
    • on wounds
    • 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 one to two drops to the affected area not more than 3 to 4 times daily. Massage gently.
    • children under 3 years of age and pregnant women: do not use, consult a physician
    • refer to the above warnings; use otherwise than as directed may be dangerous

  • STORAGE AND HANDLING

    Other information

    • keep tightly sealed
    • store at or below 30º C (86º F), away from direct sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients eucalyptus oil, fragrance, lavender oil, and peppermint oil.


  • QUESTIONS

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

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

  • PRINCIPAL DISPLAY PANEL

    WHITE FLOWER ANALGESIC BALM FLORAL SCENTED  NDC-48256-0011-1  0.338 fl oz (10 mL)IMAGE OF CARTON 10ML


  • 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 FLORAL SCENTED 
    camphor, menthol and methyl salicylate oil
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:48256-0011
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5.4 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 13.0 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 35.8 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:48256-0011-1 10 mL in 1 BOTTLE, GLASS
    2 NDC:48256-0011-2 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 07/30/2010
    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(48256-0011)
    Establishment
    Name Address ID/FEI Business Operations
    MACAU-UNION PHARMACEUTICAL LTD 448605614 repack(48256-0011)