BACITRACIN ZINC- bacitracin zinc ointment 
Rugby Laboratories

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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Rugby Bacitracin Zinc Ointment

Active Ingredient

Bacitracin Zinc 500 Units per gram

Purpose

First Aid Antibiotic

Uses

First Aid to help prevent infection in

Warnings

For External Use Only.

Do Not Use

Ask Doctor before Use

In care of deep puncture wounds, animal bites, or serious burns.

Stop Use and Ask Doctor if

Directions

Inactive Ingredients

Aloe barbadensis leaf juice, mineral oil, petrolatum

Questions

Call 1-800-645-2158

Keep out of reach of children

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

Other Information

Store Between 15° to 25°C (59° to 77°F)

Lot No. and Expiration Date: See box and tube crimp

Distributed By:

RUGBY LABORATORIES

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

1-800-645-2158

Made in China

Packaging

370817 RUGBY BACITRACIN ZINC OINTMENT 1OZ 090621 CDER

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1263
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
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1263-281 in 1 BOX04/15/2020
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/15/2020
Labeler - Rugby Laboratories (079246066)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 7/2023
Document Id: 004e078b-ff10-c177-e063-6394a90a3654
Set id: ac3c9897-c812-1360-e053-2a95a90ad591
Version: 3
Effective Time: 20230712
 
Rugby Laboratories