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
  • 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 September 6, 2021

If you are a consumer or patient please visit this version.

  • 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 not finalpart34806/11/2010
    Labeler - HOE HIN PAK FAH YEOW MANUFACTORY LTD (686359001)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOE HIN PAK FAH YEOW MFY LTD686212961manufacture(48256-0002)