ADVANCED FIRST AID BACITRACIN- bacitracin zinc ointment

Advanced First Aid Bacitracin by

Drug Labeling and Warnings

Advanced First Aid Bacitracin by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Bacitracin Zinc 500 units

PURPOSE

first aid antibiotic

INDICATIONS & USAGE

Uses:

First aid to help prevent infection in: minor cuts scrapes burns

WARNINGS

Warnings:

for external use only

DO NOT USE

Do not use :

in the eyes

if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock

over large areas of the body

longer than 1 week unless directed by a doctor

STOP USE

Stop use and ask a doctor if:

before use in case of deep puncture wounds, animal bites or serious burns

if the condition persists or gets worse

if a rash or other allergic reaction develops

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other Information:

Tamper Evident. Do not use if packet is torn, cut or opened.

Avoid excessive heat and humidity

Store at a controlled room temperature 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENT

Inactive Ingredients:

white petrolatum

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED FIRST AID BACITRACIN 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500   in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-400-53	369 g in 1 JAR; Type 0: Not a Combination Product	10/18/2016
2	NDC: 67060-400-28	28 g in 1 TUBE; Type 0: Not a Combination Product	10/18/2016
3	NDC: 67060-400-47	144 in 1 CARTON	10/18/2016
3	NDC: 67060-400-09	0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	10/18/2016

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-400)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-400)