BACITRACIN - bacitracin ointment
Dynarex Corporation

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.

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1162_1163_Bacitracin_Ointment

Active ingredient Purpose
Bacitracin 500 Units Antibiotic

Uses:

First aid to help prevent infection in:

Minor cuts
scrapes
burns

Warnings:

For external use only

Directions:

clean the affected areas
apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
may be covered with a sterile bandage

Stop use and ask a doctor if

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

Do not use:

if you are allergic to any of the ingredients
in the eyes
over large areas of the body
longer than 1 week unless directed by a doctor

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Ask a doctor before use:

in case of deep or puncture wounds
animal bites
serious burns

Other information

store at controlled room temperature 15°-30° C (59°-86° F)

Inactive ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Bacitracin Ointment:

1162_1163_Bacitracin_Ointment

BACITRACIN
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:67777-219
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN (BACITRACIN )	BACITRACIN	500 [iU] in 1 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL
PETROLATUM

#	Item Code	Package Description
Packaging
1	NDC:67777-219-01	72 in 1 CASE
1		28.35 g in 1 TUBE
2	NDC:67777-219-04	72 in 1 CASE
2		14.17 g in 1 TUBE
3	NDC:67777-219-06	12 in 1 CASE
3		144 in 1 BOX
3		0.5 g in 1 PACKET
4	NDC:67777-219-07	12 in 1 CASE
4		144 in 1 BOX
4		0.9 g in 1 PACKET
5	NDC:67777-219-05	72 in 1 CASE
5		56.7 g in 1 TUBE
6	NDC:67777-219-02	72 in 1 CASE
6		113.4 g in 1 TUBE
7	NDC:67777-219-03	12 in 1 CASE
7		425.3 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333	12/01/2009

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Name	Address	ID/FEI	Business Operations
Establishment
Galentic Pharma India Private Limited		918531450	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Sion Biotext Medical		532775194	manufacture

Name	Address	ID/FEI	Business Operations
Establishment
Choice Laboratories		650070394	manufacture

Revised: 7/2010

Document Id: f2199092-bfee-4639-bc56-34bf58adeddc

Set id: e8e4f5e5-0506-4a68-b9b7-19c48b9ae053

Version: 3

Effective Time: 20100720

Dynarex Corporation