WHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL, METHYL SALICYLATE) OIL [MACAU-UNION PHARMACEUTICAL LTD]

WHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL, METHYL SALICYLATE) OIL [MACAU-UNION PHARMACEUTICAL LTD]
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NDC 63047-0002-1, 63047-0002-2, 63047-0002-3, 63047-0002-4
Set ID c1632cd8-fe9a-408e-8624-d98efe3c4815
Category HUMAN OTC DRUG LABEL
Packager MACAU-UNION PHARMACEUTICAL LTD
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients

    Camphor 6%

    Menthol 15%

    Methyl salicylate 40%

  • PURPOSE

    Purpose
    External analgesic
    External analgesic
    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
      • 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 4 times daily.
    • For younger children, consult your doctor.
  • STORAGE AND HANDLING

    Other information

    • keep container tightly closed
    • store at 15° to 30°C (59° to 86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients Eucalyptus oil, lavender oil and peppermint oil.

  • QUESTIONS

    Questions or comments? +1-626-823-9933 M-F 9am to 5pm

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

  • PRINCIPAL DISPLAY PANEL

    WHITE FLOWER ANALGESIC BALM

    NDC 48256-0002-1

    0.676 fl oz (20 ml)

    20 ml box

  • INGREDIENTS AND APPEARANCE
    WHITE FLOWER ANALGESIC BALM 
    camphor, menthol, methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63047-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)6 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14.5 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE40.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63047-0002-11 in 1 BOX10/01/2018
    120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:63047-0002-21 in 1 BOX10/01/2018
    210 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    3NDC:63047-0002-31 in 1 BOX10/01/2018
    35 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    4NDC:63047-0002-41 in 1 BOX10/01/2018
    42.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/11/2010
    Labeler - MACAU-UNION PHARMACEUTICAL LTD (448605614)
    Establishment
    NameAddressID/FEIBusiness Operations
    MACAU-UNION PHARMACEUTICAL LTD448605614manufacture(63047-0002)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOE HIN PAK FAH YEOW MANUFACTORY LTD686212961manufacture(63047-0002)

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