drug facts

drug facts
SPL v1
SPL
SPL Set ID e7f5fdf0-1ce4-4f8b-af19-155690ca63be
Route
topical
Published
Effective Date 2011-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 [USP'U]) neomycin (3.5 mg) polymyxin b (5000 [USP'U])
Inactive Ingredients
petrolatum mineral oil propanediol methylparaben propylparaben

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2011-08-19

Description

Active Ingredients Bacitracin Zinc 400U Neomycin 3.5mg Polymyxin B sulfate 5000U


Medication Information

Warnings and Precautions
Warnings

For external use only
Active Ingredient
Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5mg

Polymyxin B sulfate 5000U
Indications and Usage
Uses   first aid to help prevent infection in    minor cuts    scrapes   burns
Dosage and Administration
Directions

Clean the affected area and dry thoroughly

Apply a 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
Description

Active Ingredients Bacitracin Zinc 400U Neomycin 3.5mg Polymyxin B sulfate 5000U

Section 42229-5
Other information

Store at 68 to 77F (20C-25C)  See carton or tube crimp for lot number and expiration date
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops
Section 50569-3
Ask a doctor before use on • on deep puncture wounds, animal bites, or serious burns
Section 50570-1
Do not use  • in the eyes    if you are allergic to any of the ingredients    longer than 1 week unless directed by a doctor    over large areas of the body
Section 51727-6
Inactive ingredients Petrolatum, Mineral oil, Ozocerite, Propanediol, Methylparaben, Propylparaben
Section 51945-4
Package Label



Section 55105-1
Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic


Structured Label Content

Warnings and Precautions (34071-1)
Warnings

For external use only
Active Ingredient (55106-9)
Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5mg

Polymyxin B sulfate 5000U
Indications and Usage (34067-9)
Uses   first aid to help prevent infection in    minor cuts    scrapes   burns
Dosage and Administration (34068-7)
Directions

Clean the affected area and dry thoroughly

Apply a 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
Section 42229-5 (42229-5)
Other information

Store at 68 to 77F (20C-25C)  See carton or tube crimp for lot number and expiration date
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops
Section 50569-3 (50569-3)
Ask a doctor before use on • on deep puncture wounds, animal bites, or serious burns
Section 50570-1 (50570-1)
Do not use  • in the eyes    if you are allergic to any of the ingredients    longer than 1 week unless directed by a doctor    over large areas of the body
Section 51727-6 (51727-6)
Inactive ingredients Petrolatum, Mineral oil, Ozocerite, Propanediol, Methylparaben, Propylparaben
Section 51945-4 (51945-4)
Package Label



Section 55105-1 (55105-1)
Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic


Advanced Ingredient Data


Raw Label Data

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