BACITRACIN ZINC ointment

Bacitracin Zinc by

Drug Labeling and Warnings

Bacitracin Zinc by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Bacitracin Zinc 500 Units per gram

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
• longer than 1 week unless directed by a doctor

Ask Doctor before Use

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

Stop Use and Ask Doctor if

• The condition persists or gets worse
• A rash or allergic reaction develops

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

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

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1263
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1263-28	1 in 1 BOX	04/15/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	04/15/2020

Labeler - Rugby Laboratories (079246066)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)