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.

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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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ADVANCED FIRST AID BACITRACIN 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500   in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67060-400-53369 g in 1 JAR; Type 0: Not a Combination Product10/18/2016
2NDC:67060-400-2828 g in 1 TUBE; Type 0: Not a Combination Product10/18/2016
3NDC:67060-400-47144 in 1 CARTON10/18/2016
3NDC:67060-400-090.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/18/2016
Labeler - ADVANCED FIRST AID, INC. (114477180)
Registrant - ADVANCED FIRST AID, INC. (114477180)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA SEAL CORPORATION085752004pack(67060-400)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-400)

Revised: 10/2016
Document Id: c1cda234-86c1-4181-8842-ed40cbbb3d39
Set id: 024bc706-2da7-4e41-b1bc-60fa1b351463
Version: 1
Effective Time: 20161018
 
ADVANCED FIRST AID, INC.