BACITRACIN ZINC- bacitracin zinc ointment 
Trifecta Pharmaceuticals USA LLC

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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Globe Bacitracin Zinc Ointment

Active Ingredient

Bacitracin Zinc 500 Units

Purpose

First Aid Antibiotic

Uses

First Aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

For External Use Only.

Do Not Use

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

Stop Use and Ask Doctor if

  • Before use in case of deep puncture wounds, animal bites or serious burns
  • The condition persists or gets worse
  • A rash or allergic reaction develops

Directions

  • Clean the affected area
  • Apply a small amount of the 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

Inactive Ingredients

Mineral oil, white petrolatum

Questions

Call 1-888-296-9067

Fax: 1-888-878-3609

Online: www.trifecta-pharma.com

Reorder No. 1013SL

Storage Information

Store at room temperature 15° to 25°C (59° to 77°F).

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

Made in China

Globe bacitracin 0.9g CDER

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-098-09144 in 1 CARTON03/10/2022
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/10/2022
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 3/2022
Document Id: d9f26b72-e1e3-569d-e053-2a95a90ae565
Set id: d9f2702c-a514-cb69-e053-2a95a90a29a9
Version: 3
Effective Time: 20220309
 
Trifecta Pharmaceuticals USA LLC