Advanced First Aid Bacitracin: Package Insert and Label Information

ADVANCED FIRST AID BACITRACIN- bacitracin zinc ointment
ADVANCED FIRST AID, INC.

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.

Bacitracin Zinc 500 units

first aid antibiotic

Uses:

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

Warnings:

• for external use only

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 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.

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:

• 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 Ingredients:

white petrolatum

adv Bacitracin jar
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adv Bacitracin Tube
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advBacitracinPacket
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advBAcitracinCarton
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ADVANCED FIRST AID BACITRACIN
bacitracin zinc ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-400
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 500 in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67060-400-53 369 g in 1 JAR None
2 NDC:67060-400-28 28 g in 1 TUBE None
3 NDC:67060-400-47 144 PACKET in 1 CARTON contains a PACKET (67060-400-09)
3 NDC:67060-400-09 0.9 g in 1 PACKET This package is contained within the CARTON (67060-400-47)
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 Operations
ULTRA SEAL CORPORATION 085752004 pack (67060-400)
Establishment
Name Address ID/FEI Operations
ULTRA TAB LABORATORIES, INC. 151051757 manufacture (67060-400)

Revised: 10/2016 ADVANCED FIRST AID, INC.

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