Label: BALM STICK- camphor, menthol, methyl salicylate stick

  • 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 December 27, 2021

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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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