Label: TINCTURE MERTHIOLATE- benzalkonium chloride tincture

  • 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 03/13

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

  • Active Ingredient

    Benzalkonium chloride 0.13%

    Purpose

    First Aid Antiseptic

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  • Uses

    first aid to help prevent infection in minor:
    cuts - scrapes - burns - insect bites

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  • Warnings

    For external use only.
    Consult a doctor before use if you have - deep or puncture wounds - animal bites - serious burns

    When using this product

    • do not use in or near the eyes
    • do not apply in large quantities or over large areas of the body
    • do not apply over raw surtaces or blistered areas

    Stop use and consult a doctor if

    • redness, irritation, swelling or pain persists or increases, or il infection or rash occurs
    • symptoms persist for more than 7 days, or clear up and occur again within a lew days

    Keep out of reach of children.

    II swallowed, get medical help or contact a Poison Control Center immediately.

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  • Directions

    • adults and children 2 years of age and older: clean the affected area
    • apply a small amount of this product to the area using the enclosed applicator or a cotton-tipped applicator 1 to 3 times daily _ may be covered with a sterile bandage (let dry first)
    • children under 2 years, ask a doctor
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  • Other Information

    • medication will stain skin and clothing
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  • Inactive Ingredients

    acetone, alcohol, DandC red no. 22, purified water

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  • Product Labeling

    De La Cruz

    Tincture Merthiolate

    50% Alcohol

    Mercury Free

    For external use only

    First Aid Antiseptic

    1 FL OZ

    Manufactured by
    De La Cruz Products
    A Division of DLC Laboratories, Inc.
    Paramount, CA 90723 USA
    Questions: 1-800-858-3889
    www.dlclabs.com

    Warnings: do not use if plastic seal around cap is broken or removed. For external use only.

    Merthiolate Tincture

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  • INGREDIENTS AND APPEARANCE
    TINCTURE MERTHIOLATE 
    benzalkonium chloride tincture
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24286-1532
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACETONE  
    ALCOHOL  
    D&C RED NO. 22  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24286-1532-7 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/22/2013
    Labeler - DLC Laboratories, Inc (093351930)
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