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

WHITE FLOWER ANALGESIC BALM (CAMPHOR, MENTHOL, AND METHYL SALICYLATE) OIL [JELMA PHILIPPINES INC]
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NDC 51681-0001-1, 51681-0001-2, 51681-0001-3, 51681-0001-4
Set ID b047dade-a69e-40f5-b157-882bf2346796
Category HUMAN OTC DRUG LABEL
Packager JELMA PHILIPPINES INC
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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