WHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [JELMA PHILIPPINES INC]

WHITE FLOWER ANALGESIC BALM FLORAL SCENTED (CAMPHOR, MENTHOL AND METHYL SALICYLATE) OIL [JELMA PHILIPPINES INC]
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NDC 51681-0011-1, 51681-0011-2
Set ID e323aa81-675c-4fe2-b643-9bd1fcebdaa4
Category HUMAN OTC DRUG LABEL
Packager JELMA PHILIPPINES INC
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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