Label: WHITE FLOWER ANALGESIC BALM- camphor, menthol, and 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 October 15, 2018

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 6%
    Menthol 15%
    Methyl salicylate 40%

  • PURPOSE

    Purpose
    External analgesic

  • INDICATIONS & USAGE

    Uses For the temporary relief of minor aches and pains of muscles and joints due to

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • DO NOT USE

    Do not use

    • on wounds
    • on irritated or damaged skin
    • on the face
    • otherwise than as directed
  • WARNINGS

    Warnings
    For external use only

  • 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 a few drops then gently rub into the affected area not more than 3 to 4 times daily.
    • Children under 3 years of age: Do not use, consult your doctor.
    • Refer to the above warnings; use otherwise than as directed may be dangerous.
  • 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 or comments? (888)221-3496 M-F 9am to 5pm

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

    WHITE FLOWER ANALGESIC BALM  NDC-51681-0001-1  0.67 fl oz (20mL)IMAGE OF CARTON 20ML

  • INGREDIENTS AND APPEARANCE
    WHITE FLOWER ANALGESIC BALM 
    camphor, menthol, and methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51681-0001
    Route of AdministrationTRANSDERMAL
    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) MENTHOL14.6 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE40 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:51681-0001-120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/14/2010
    2NDC:51681-0001-210 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/14/2010
    3NDC:51681-0001-42.5 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/14/2010
    4NDC:51681-0001-35 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/14/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/14/2010
    Labeler - JELMA PHILIPPINES INC (721085447)
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