Label: BAROX BODY CARE MASSAGE- menthol gel 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient: Menthol 2%

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  • INACTIVE INGREDIENT

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

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  • PURPOSE

    Purpose: Topical Analgesic

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  • WARNINGS

    Warnings: For external use only

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  • 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.

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  • USES

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

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  • 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

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  • 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

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  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    BAROX  BODY CARE MASSAGE
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55692-100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (MENTHOL) Menthol 2.4 mg  in 120 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    PROPYLENE GLYCOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55692-100-01 120 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/01/2012
    Labeler - Dr.JangLab Inc. (688380051)
    Registrant - Dr.JangLab Inc. (688380051)
    Establishment
    Name Address ID/FEI Business Operations
    Dr.JangLab Inc. 688380051 manufacture(55692-100)
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