Label: ACME SMALL CUTS AND BURNS - benzalkonium chloride, lidocaine, bacitracin zinc, neomycin sulfate, polymyxin b sulfate
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- 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.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- 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
Close - WARNINGS
- 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
- DOSAGE & ADMINISTRATION
Directions: Clean affected area, Apply small amount not more than 3 times daily.
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May be covered with a sterile bandage. - STORAGE AND HANDLING
- DESCRIPTION
- 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.
Close - ACTIVE INGREDIENT
- PURPOSE
Use: For Professional and Hospital use. Helps
prevent infection. Antiseptic cleansing of face,
hands and body without soap and water. Close - WARNINGS
- 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
- WHEN USING
Directions: Tear open packet, unfold towelette
Close
and use to cleanse desired skin area. Discard
towelette appropriately after single use.
- INACTIVE INGREDIENT
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
Antiseptic Towelette
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Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AID
- ACTIVE INGREDIENT
Active Ingredient: .........Bacitracin Zinc 400 units
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Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
Polymyxin B Sulfate 5000 units
- PURPOSE
- WARNINGS
- DO NOT USE
Do not use: in eyes; over large areas of the body;
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If allergic to any of the ingredients; for more than one week unless directed by a physician.
- STOP USE
Stop use and consult a doctor:
if the condition persists or gets worse; a rash or other allergic reaction develops Close - KEEP OUT OF REACH OF CHILDREN
- 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
Close - STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
Genuine Triple Antibiotic
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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.
- 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.
Close - INGREDIENTS AND APPEARANCE
ACME SMALL CUTS AND BURNS
benzalkonium chloride, lidocaine, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kitProduct 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 creamProduct 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 liquidProduct 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 ointmentProduct 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) CloseEstablishment Name Address ID/FEI Business Operations GFA Production ( Xiamen) Co., Ltd 421256261 manufacture