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Single Antibiotic with bacitracin

Dosage form: ointment
Ingredients: bacitracin zinc 400[USP'U] in 1g
Labeler: Safetec of America
NDC Code: 61010-5601

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.

Drug Facts

Active Ingredient (in each gram)

Bacitracin zinc (500 units bacitracin)

Purpose

First Aid Antibiotic

Uses:

First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings:

For external use only. Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center directly.

Do Not Use:
  • in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if allergic to any of the ingredients

Stop use, ask a doctor if:
  • condition persists or gets worse
  • a rash or allergic reaction develops

Directions:
  • clean affected area
  • apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily
  • may cover with a sterile bandage

Inactive ingredients:

mineral oil, petrolatum

Questions or Comments?

1-800-456-7077

Principal Display Panel - Box Label

NDC 61010-5601-2

Safetec

First Aid

Single Antibiotic Ointment

• with Bacitracin

• First Aid to Help Prevent
Infection In Minor Cuts,
Scrapes, and Burns

Reorder No. 53310

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

Principal Display Panel - Pouch Label

Safetec

Single Antibiotic
Ointment

(Bacitracin)

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

Principal Display Panel - Box Label

NDC 61010-6601-3

Safetec

First Aid

Single Antibiotic Ointment

• with Bacitracin

• First Aid to Help Prevent
Infection In Minor Cuts,
Scrapes, and Burns

25 Packets

Each Packet Net. Wt. 0.9gm

Principal Display Panel - Pouch Label

Safetec

Single Antibiotic
Ointment

(Bacitracin)

0.9 g (1/32 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

SINGLE ANTIBIOTIC WITH BACITRACIN 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5601
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bacitracin zinc (bacitracin) bacitracin400 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:61010-5601-2144 POUCH in 1 BOX
1NDC:61010-5601-10.9 g in 1 POUCH
2NDC:61010-5601-325 POUCH in 1 BOX
2NDC:61010-5601-10.9 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B11/13/2008
Labeler - Safetec of America (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(61010-5601)

 
Safetec of America

Medically reviewed on Feb 2, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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