Bacitracin Zinc Ointment Usp

Bacitracin Zinc Ointment Usp
SPL v1
SPL
SPL Set ID 0a970384-1155-400b-9c73-c3e4563788be
Route
TOPICAL
Published
Effective Date 2016-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U])
Inactive Ingredients
Aloe Vera Leaf Light Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-04-07

Description

Bacitracin Zinc 500 units

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 500 units

Uses

● first aid to help prevent infection in minor cuts scrapes ● burns

Section 42229-5

100% GUARANTEED

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC

www.trifecta-pharma.com

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

For external use only.

Do not use ● in the eyes ●over large areas of the body ● if you are allergic to any of the ingredients ● longer than 1 week unless directed by a healthcare professional

Ask a healthcare professional before use in care of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a healthcare professional if ● the condition persists or gets worse ● a rash or allergic reaction develops

Packaging

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

Drug Facts

Active Ingredient

Bacitracin Zinc 500 units

Other Information

● store between15° to 25°C ( 59° to 77°F) ● Lot No & Expiration Date: See box and tube crimp.

Inactive Ingredient:

aloe vera gel, light mineral oil, white petrolatum


Structured Label Content

Uses

● first aid to help prevent infection in minor cuts scrapes ● burns

Section 42229-5 (42229-5)

100% GUARANTEED

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC

www.trifecta-pharma.com

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

First Aid Antibiotic

Warnings

For external use only.

Do not use ● in the eyes ●over large areas of the body ● if you are allergic to any of the ingredients ● longer than 1 week unless directed by a healthcare professional

Ask a healthcare professional before use in care of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a healthcare professional if ● the condition persists or gets worse ● a rash or allergic reaction develops

Packaging

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

Drug Facts

Active Ingredient (Active ingredient)

Bacitracin Zinc 500 units

Other Information (Other information)

● store between15° to 25°C ( 59° to 77°F) ● Lot No & Expiration Date: See box and tube crimp.

Inactive Ingredient: (Inactive ingredient:)

aloe vera gel, light mineral oil, white petrolatum


Advanced Ingredient Data


Raw Label Data

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