Label: WHITE FLOWER ANALGESIC BALM- camphor, menthol, methyl salicylate oil

  • 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 March 11, 2019

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  • 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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