BALM STICK (CAMPHOR, MENTHOL, METHYL SALICYLATE) STICK [INDO ABADI SARI MAKMUR, PT]

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BALM STICK (CAMPHOR, MENTHOL, METHYL SALICYLATE) STICK [INDO ABADI SARI MAKMUR, PT]
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NDC 70815-001-20
Set ID 3756ef07-6317-4c0e-b036-080e964128fa
Category HUMAN OTC DRUG LABEL
Packager Indo Abadi Sari Makmur, PT
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Methyl Salicylate  7%

    Menthol  13%

    Camphor  12%

  • Purpose

    Methyl Salicylate     External Analgesic

    Menthol         External Analgesic

    Camphor    External Analgesic

  • Uses

    Relieves muscle pains, lumbago, insect bites, itching

  • DIRECTIONS

    Apply to the affected area as needed.

  • Warnings

    External Use Only. Do not use for children below 2 years of age. Avoid direct application into the nostrils.

  • Warnings

    Keep out of reach of children.

  • Warnings

    Stop use and ask 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, vomitting, abdominal discomfort, diarrhea, or skin rash occurs

    When using for pain of arthritis: pain persits for more than 10 days, redness is present, in conditions affecting children 12 years of age.

  • Other Information

    Keep container tightly closed. Store at 16 to 30 degrees centigrade (69 to 86 Farenheit).

  • Inactive Ingredients

    Eucalyptus Oil, Capsicum, Peppermint Oil, Borneol

  • Drug Facts

    image

  • INGREDIENTS AND APPEARANCE
    BALM STICK 
    camphor, menthol, methyl salicylate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70815-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE7 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL13 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CAPSICUM (UNII: 00UK7646FG)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    BORNEOL (UNII: M89NIB437X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70815-001-201 in 1 CARTON07/31/2016
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/31/2016
    Labeler - Indo Abadi Sari Makmur, PT (728715202)
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