Label: WHITE FLOWER ANALGESIC BALM FLORAL SCENTED- 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 July 30, 2010

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  • ACTIVE INGREDIENT

    Active ingredients
    Camphor 5.4%
    Menthol 13.1%
    Methyl salicylate 36%

  • PURPOSE

    Purpose

    External analgesic


    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 irritated or damaged skin
    • on wounds
    • 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
    • when using for pain of arthritis:
      • pain persists for more than 10 days
      • redness is present
      • in conditions affecting children under 12 years of ag
  • 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 one to two drops to the affected area not more than 3 to 4 times daily. Massage gently.
    • children under 3 years of age and pregnant women: do not use, consult a physician
    • refer to the above warnings; use otherwise than as directed may be dangerous
  • STORAGE AND HANDLING

    Other information

    • keep tightly sealed
    • store at or below 30º C (86º F), away from direct sunlight
  • INACTIVE INGREDIENT

    Inactive ingredients eucalyptus oil, fragrance, lavender oil, and peppermint oil.

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

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

    WHITE FLOWER ANALGESIC BALM FLORAL SCENTED  NDC-51681-0011-1  0.338 FL OZ (10 ML)IMAGE OF CARTON 10ML

  • INGREDIENTS AND APPEARANCE
    WHITE FLOWER ANALGESIC BALM FLORAL SCENTED 
    camphor, menthol and methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51681-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5.4 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL13.0 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE35.8 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51681-0011-110 mL in 1 BOTTLE, GLASS
    2NDC:51681-0011-25 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/20/2010
    Labeler - JELMA PHILIPPINES INC (721085447)
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