Label: BAROX- menthol gel

  • 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 August 15, 2012

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  • Active ingredient

    Active ingredient: Menthol 2.5%

  • Inactive ingredient

    Inactive ingredients:
    Water, Alcohol, Propylene Glycol, Germanium Dioxide, Allantoin, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Disodium EDTA, Methylparaben

  • Purpose

    Purpose: Topical Analgesic

  • Warnings

    Warnings: For external use only

  • Keep out of reach of children

    Keep out of reach of children:
    Keep out of reach of children to avoid accidental ingestion.
    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Uses

    Uses:
    Temporarily relieves the minor pains of muscles and joints associated with:
    simple backache and arthritis

  • Dosage and administration

    Dosage and administration:
    adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    children under 12 years of age: ask a doctor

  • Description

    Ask a doctor before use if you have redness over the affected area.

    Do not use: on wounds or damaged skin

    Stop use and ask a doctor if excessive skin irritation occurs.

    Other information:
    Store in a cool dry place with lid closed tightly

    Question
    Contact: smyou2@nate.com

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BAROX 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52227-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 82.2 g  in 120 mL
    ALCOHOL (UNII: 3K9958V90M) 18 g  in 120 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4.8 g  in 120 mL
    GERMANIUM DIOXIDE (UNII: 5O6CM4W76A) 0.96 g  in 120 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.6 g  in 120 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52227-100-01120 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2012
    Labeler - KTAIGA CO., LTD. (557819324)
    Registrant - KTAIGA CO., LTD. (557819324)
    Establishment
    NameAddressID/FEIBusiness Operations
    KTAIGA CO., LTD.557819324manufacture(52227-100)
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