Label: ACME SMALL CUTS AND BURNS - benzalkonium chloride, lidocaine, bacitracin zinc, neomycin sulfate, polymyxin b sulfate

  • NDC Code(s): 0924-1805-01, 52124-0001-1, 52124-0003-1, 52124-0004-1
  • Packager: Acme United Corp.
  • 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 June 14, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredients:                            

    Benzalkonium Chloride 0.13%

    Lidocaine HCL 0.5%

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  • PURPOSE

    Purpose: First aid antiseptic, external analgesic

    Uses: First aid to help prevent infection and for
    the temporary relief of pain and itching associated with:
    minor cuts, scrapes, burns
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  • WARNINGS

    Warning:  For external use only.

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  • DO NOT USE

    Do not use:  in eyes, in large quantities, over raw blistered areas,

    or on deep puncture wounds, animal bites or serious burns, for more than one week

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested, contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions: Clean affected area, Apply small amount not more than 3 times daily.

    May be covered with a sterile bandage.

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  • STORAGE AND HANDLING

    Other Information:

    Store at room temperature Close
  • DESCRIPTION

    LOT/EXP:                                    Made in CHINA

    20130301

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  • PRINCIPAL DISPLAY PANEL

    Genuine First Aid Burn Cream

    Antiseptic Pain Relief With Aloe

    Net Wt 0.9g (1/32 oz)

    Manufactured in CHINA for

    Genuine First Aid.
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  • ACTIVE INGREDIENT

    Active Ingredient:                             Purpose

    Benzalkonium Chloride 0.40%... First Aid Antiseptic

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  • PURPOSE

    Use: For Professional and Hospital use.  Helps

    prevent infection.  Antiseptic cleansing of face,

    hands and body without soap and water. Close
  • WARNINGS

    Warning:    For external use only.
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  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children:  If swallowed, get medical help

    or contact a Poison Control Center right away. Close
  • STOP USE

    Stop use if unusual redness, swelling or other symptoms occur.

    Consult a physician immediately. Close
  • DO NOT USE


    Do not use in the eyes or over large areas of

    the body.
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  • WHEN USING

    Directions: Tear open packet, unfold towelette

    and use to cleanse desired skin area.  Discard

    towelette appropriately after single use.


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  • INACTIVE INGREDIENT

    Inactive Ingredient:    Purified water

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  • DESCRIPTION

    LOT/EXP:                                    Made in CHINA

    20130301

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  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

    Genuine First Aid LLC, Clearwater FL 33755

    www.GenuineFirstAid.com

    GENUINE FIRST AID

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  • ACTIVE INGREDIENT

    Active Ingredient: .........Bacitracin Zinc 400 units

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

    Polymyxin B Sulfate 5000 units

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  • PURPOSE

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

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  • WARNINGS

    Warnings:

    For external use only.

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  • 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.

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  • STOP USE

    Stop use and consult a doctor:

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested, contact a Poison

    Control Center right away.

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  • WHEN USING



    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

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  • STORAGE AND HANDLING

    Other information:

    Store at room temperature.

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  • PRINCIPAL DISPLAY PANEL


    Genuine 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.

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  • PRINCIPAL DISPLAY PANEL

    Small Cuts and Burns

    10 Adhesive Plastic Bandages 3/4"x3"
    10 Junior Plastic Bandages 3/8"x1-1/2"
    5 Adhesive Plastic Bandages 1"x3"
    1 Knuckle Fabric Bandage
    10 Adhesive Spot Bandages 7/8"x7/8"
    1 Fingertip Fabric Bandage
    1 Elbow/Knee Adhesive Bandage
    1 Burn Cream
    5 Antiseptic Towelettes
    1 Antibiotic Ointment
    2 Sterile Gauge Pads 2"x2"
    10 Cotton Tipped Applicators


    Manufactured in China for:

    Acme United Corporation
    60 Round Hill Road
    Fairfield, CT 06824

    www.acmeunited.com

    © 2009 Acme United Corporation
    PhysiciansCare® and are
    registered Trademarks of Acme
    United Corporation

    Physicians CARE

    Copyright C 2009 Genuine First Aid LLC. All rights reserved.
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  • INGREDIENTS AND APPEARANCE
    ACME SMALL CUTS AND BURNS 
    benzalkonium chloride, lidocaine, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-1805
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0924-1805-01 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 PACKAGE 0.9 g
    Part 2 5 PACKAGE 4 mL
    Part 3 1 TUBE 0.5 g
    Part 1 of 3
    GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE 
    benzalkonium chloride, lidocaine cream
    Product Information
    Item Code (Source) NDC:52124-0004
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.5 g  in 100 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0004-1 0.9 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part345 04/30/2010
    Part 2 of 3
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride liquid
    Product Information
    Item Code (Source) NDC:52124-0001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.40 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0001-1 0.8 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333 04/30/2010
    Part 3 of 3
    GENUINE TRIPLE ANTIBIOTIC 
    bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
    Product Information
    Item Code (Source) NDC:52124-0003
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 5000 [iU]  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0003-1 0.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333 04/30/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333 04/30/2010
    Labeler - Acme United Corp. (001180207)
    Establishment
    Name Address ID/FEI Business Operations
    GFA Production ( Xiamen) Co., Ltd 421256261 manufacture
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