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

  • NDC Code(s): 48256-0002-1, 48256-0002-2, 48256-0002-3, 48256-0002-4
  • Packager: HOE HIN PAK FAH YEOW MANUFACTORY LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2023

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  • 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
    • 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 15º to 30ºC (59º to 86ºF)
  • INACTIVE INGREDIENT

    Inactive ingredients

    Eucalyptus oil, lavender oil and peppermint oil.

  • QUESTIONS

    Questions? +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

    20mL boxWhite Flower Analgesic Balm NDC-48256-0002 0.676 fl oz (20mL)

  • INGREDIENTS AND APPEARANCE
    WHITE FLOWER ANALGESIC BALM 
    camphor, menthol and methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48256-0002
    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:48256-0002-120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/01/2018
    2NDC:48256-0002-210 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/01/2018
    3NDC:48256-0002-42.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/01/2018
    4NDC:48256-0002-35 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/11/2010
    Labeler - HOE HIN PAK FAH YEOW MANUFACTORY LTD (686359001)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOE HIN PAK FAH YEOW MFY LTD686212961manufacture(48256-0002)
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