Label: TINCTURE MERTHIOLATE- benzalkonium chloride tincture

  • 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 March 17, 2022

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

  • Active Ingredient

    Benzalkonium chloride 0.13%

    Purpose

    First Aid Antiseptic

  • Uses

    First aid antiseptic to help prevent infection in minor:

    cuts - scrapes - burns

  • Warnings

    For external use only.

    Flammable. Keep away from sparks, heat and fire.

    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
    • do not use longer than 1 week unless directed by a doctor

    Stop use and consult a doctor if

    • the condition persists or gets worse

    Keep out of reach of children.

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

  • Directions

    • adults and children 2 years of age and older: clean the affected area
    • apply a small amount of this product to the area 1 to 3 times daily _ may be covered with a sterile bandage. If bandaged, let dry first
    • children under 2 years of age: ask a doctor
  • Other Information

    • will stain skin and clothing
  • Inactive Ingredients

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

  • Product Labeling

    De La Cruz Merthiolate

    Tincture Merthiolate

    48% Alcohol

    Mercury Free

    First Aid Antiseptic

    For External Use Only

    1 FL OZ (30 mL)

    Distributed by

    De La Cruz Products

    A Division of DLC Laboratories, Inc.

    Paramount, CA 90723 USA

    Questions: 1-800-858-3889

    www.dlclabs.com

    Warnings: FLAMMABLE, KEEP AWAY FROM SPARKS, HEAT AND FIRE.

  • INGREDIENTS AND APPEARANCE
    TINCTURE MERTHIOLATE 
    benzalkonium chloride tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-1532
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    ALCOHOL (UNII: 3K9958V90M)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24286-1532-730 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/22/2013
    Labeler - DLC Laboratories, Inc (093351930)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(24286-1532) , manufacture(24286-1532) , pack(24286-1532) , label(24286-1532)