Label: PREMIER VALUE MERTHIOALATE- benzalkonium chloride liquid

  • 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 13, 2017

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  • Premier Value Merthiolate

    Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Indications

    First aid antiseptic to help skin infection in minor: cuts, scrapes, burns, insect bites.

  • Warnings

    For external use only.

  • Ask a doctor before use if you have

    Deep or puncture wounds

    Animal bites

    Serious burns

  • When using this product do not

    Get into the eyes

    Apply over large areas of the body

    Apply over raw surfaces or blistered areas

    Use longer than one week unless directed by doctor.

  • Stop use and ask a doctor if

    Redness, swelling or pain persists or increases.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately. Soap will deactivate the effects of this product.

  • Directions

    • Adults and children 2 years and older. Clean the affected area; apply a small amount on the area 1 to 3 times daily; may be covered with a sterile bandage. If bandaged, let dry first.
    • Children under 2 yrs. of age: Consult a doctor.
  • Inactive Ingredient

    Acetone, FD&C Red No 4. Purified water.

  • Label

    image description

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE MERTHIOALATE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-437
    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)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-437-0059 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/26/2017
    Labeler - Chain Drug Consortium (101668460)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(68016-437) , analysis(68016-437) , pack(68016-437) , label(68016-437)
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