Label: CVS CUTS AND SCRAPES REFILL PACK- benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 27, 2016

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  • Active Ingredient

    Benzalkonium Chloride .13%

  • Purpose

    First Aid Antiseptic

  • Use

    For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

  • Warnings

    For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, cunsult a physician immediately.

  • KEEP OUT OF REACH OF CHILDREN

  • STOP USE

  • Do not use

    In the eyes, or over large areas of the body

  • Directions

    Tear open packet, unfold towelette and use to cleanse desired skin are. Discard towelette appropriately after single use

  • Inactive Ingredients

    Purified Water

  • Active Indredients

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

    Polymyxin B Sulfate 5000 units

  • Purpose

    Triple Antibiotic

  • Uses

    To help prevent infection in:
    minor cuts; scrapes; burns

  • Warnings

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested, contact a Poison

    Control Center right away.

  • STOP USE

    Stop use and consult a doctor:

    if the condition persists or gets worse; a rash or other allergic reaction develops

  • DO NOT USE

    Do not use: in eyes; over large areas of the body;

    If allergic to any of the ingredients; for more than one week unless directed by a physician.

  • Directions

    Directions: clean affected area; apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage

  • Storage and Handling

    Other information:

    Store at room temperature.

  • INACTIVE INGREDIENT

    Vaseline
    Mineral Oil
    Purified Water

  • Antiseptic Towelette

    Antiseptic Towelette
    GFA Production Xiamen Co., Ltd
    www.gfaproduction.com

    Antiseptic Towelette

  • PRINCIPAL DISPLAY PANEL

    Cuts & ScrapesGenuine Triple Antibiotic

    First Aid Ointment

    To Help Prevent Infection

    Each Gram Contains:

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg

    (equivalent to 3.5 mg

    Neomycin base)

    Polymyxin B Sulfate 5000 units

    Net Wt. 0.5g ; (1/64 oz)

    Manufactured in CHINA for

    GENUINE FIRST AID.

    Triple Antibiotic Ointment 10pcs

    Net wt. 0.9g (1/32oz)

    100
    Triple Antibiotic Triple Antibiotic

  • INGREDIENTS AND APPEARANCE
    CVS CUTS AND SCRAPES REFILL PACK 
    benzalkonium chloride, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-402
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-402-001 in 1 BAG; Type 0: Not a Combination Product12/01/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 18 PACKAGE 6 mL  in .8 
    Part 24 TUBE 2 g  in .9 
    Part 1 of 2
    ANTISEPTIC 
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:52124-0001
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0001-10.8 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/01/2016
    Part 2 of 2
    GENUINE TRIPLE ANTIBIOTIC 
    bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
    Product Information
    Item Code (Source)NDC:52124-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0003-00.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/16/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333A12/01/2016
    Labeler - CVS (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tender Corporation064437304manufacture(69842-402)
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