FDA Label for Acme Small Cuts And Burns
View Indications, Usage & Precautions
Acme Small Cuts And Burns Product Label
The following document was submitted to the FDA by the labeler of this product Acme United Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients:
Benzalkonium Chloride 0.13%
Lidocaine HCL 0.5%
Active Ingredient: Purpose
Benzalkonium Chloride 0.40%... First Aid Antiseptic
Active Ingredient: .........Bacitracin Zinc 400 units
Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)
Polymyxin B Sulfate 5000 units
Otc - Purpose
Purpose: First aid antiseptic, external analgesicUses: First aid to help prevent infection and forthe temporary relief of pain and itching associated with:minor cuts, scrapes, burns
Use: For Professional and Hospital use. Helpsprevent infection. Antiseptic cleansing of face,hands and body without soap and water.
Uses: To help prevent infection in:
minor cuts; scrapes; burns
Warnings
Warning: For external use only.
Warnings:
For external use only.
Otc - 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
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If ingested, contact a Poison Control Center right away.
Keep out of reach of children.
If ingested, contact a Poison
Control Center right away.
Dosage & Administration
Directions: Clean affected area, Apply small amount not more than 3 times daily.
May be covered with a sterile bandage.
Storage And Handling
Other Information:Store at room temperature
Other information:
Store at room temperature.
Description
LOT/EXP: Made in CHINA
20130301
LOT/EXP: Made in CHINA
20130301
Package Label.Principal Display Panel
Genuine First Aid Burn CreamAntiseptic Pain Relief With AloeNet Wt 0.9g (1/32 oz)Manufactured in CHINA forGenuine First Aid.
Antiseptic Towelette
Genuine First Aid LLC, Clearwater FL 33755
www.GenuineFirstAid.com
GENUINE FIRST AID
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.
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.
Otc - Stop Use
Stop use if unusual redness, swelling or other symptoms occur.
Stop use and consult a doctor:
if the condition persists or gets worse; a rash or other allergic reaction developsOtc - When Using
Directions: Tear open packet, unfold towelette
and use to cleanse desired skin area. Discard
towelette appropriately after single use.
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
Inactive Ingredient
Inactive Ingredient: Purified water
* Please review the disclaimer below.