BACITRACIN ZINC ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)

Available from:

Trifecta Pharmaceuticals USA LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First Aid Antibiotic First Aid to help prevent infection in - minor cuts - scrapes - burns - in eyes - over large areas of the body - if you are allergic to any of the ingredients - 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

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
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
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 and dry thoroughly.
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
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
Immediately.
INACTIVE INGREDIENTS
Mineral oil, white petrolatum
QUESTIONS
Call 1-888-296-9067
Fax: [phone]
Online: www.trifecta-pharma.com
Reorder No. 1013SL
STORAGE INFORMATION
Store at room temperature 15° to 25°C (59° to 77°F).
OTHER INFORMATION
Distributed By:
Trifecta Pharmaceuticals USA®
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
PACKAGING
BACITRACIN ZINC
bacitracin zinc ointment
PRODUCT INFORMATION
Trifecta Pharmaceuticals USA LLC
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69396-104
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
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:69396-104-
09
144 in 1 CARTON
04/21/2