Triple Antibiotic (Bacitracin Zinc, Polymyxin B Sulfate, And Neomycin Sulfate) Ointment [Lil' Drug Store Products, Inc.] -

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATE) OINTMENT [LIL' DRUG STORE PRODUCTS, INC.]
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NDC	66715-9731-0
Set ID	ca792dfc-c1c3-4021-8155-51d2a682973b
Category	HUMAN OTC DRUG LABEL
Packager	Lil' Drug Store Products, Inc.
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purpose
Bacitracin Zinc 400 units	First aid antibiotic
Neomycin Sulfate 5 mg (3.5 mg of Neomycin base)	First aid antibiotic
Polymyxin-B Sulfate 5000 units	First aid antibiotic

Use
first aid to help prevent infection in
- minor cuts
- scrapes
- burns
Warnings
For external use only.
Do not use
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns
Stop use and ask a doctor if
- the condition persists or gets worse
- a rash or other allergic reaction develops
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- clean the affected area
- 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
Other information
- store at 20°C to 25°C (68°F to 77°F)
- do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening
Inactive ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum
Questions?

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)
SPL UNCLASSIFIED SECTION

Product distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW
Cedar Rapids, IA 52404
PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

QUALITY
GUARANTEED

Compare to the Active Ingredients
in Neosporin®*

24 HOUR
Infection Protection

Triple Antibiotic Ointment

Bacitracin Zinc, Neomycin Sulfate, Polymyxin-B Sulfate
First Aid Antibiotic Ointment

Helps Prevent Infection in
Minor Cuts, Scrapes and Burns

NET WT 0.5 oz (14.2 g)

Lil'
Drug Store®

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate, and neomycin sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66715-9731
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	400 [iU] in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Cocoa Butter (UNII: 512OYT1CRR)
Cottonseed Oil (UNII: H3E878020N)
Olive Oil (UNII: 6UYK2W1W1E)
Sodium Pyruvate (UNII: POD38AIF08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66715-9731-0	1 in 1 CARTON	10/15/2018
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	10/15/2018

Labeler - Lil' Drug Store Products, Inc. (093103646)

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Medic

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATE) OINTMENT [LIL' DRUG STORE PRODUCTS, INC.]

Do not use

Stop use and ask a doctor if

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