S-Oint BACITRACIN OINTMENT FIRST AID ANTIBIOTIC

S-Oint BACITRACIN by

Drug Labeling and Warnings

S-Oint BACITRACIN by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

S-OINT BACITRACIN- bacitracin ointment 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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S-Oint BACITRACIN OINTMENT FIRST AID ANTIBIOTIC

Drug Facts

ACTIVE INGREDIENT

Bacitracin 500 units

PURPOSE

First aid antibiotic

USES

Helps prevent infection in minor cuts, scrapes and burns

WARNINGS

For external use only

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

Stop use and ask a doctor if
The condition persists or gets worse  A rash or other allergic reaction develops

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

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

Questions or comments?

1-800-572-6632 between 9am and 4pm EST, Monday-Friday.

OTHER INFORMATION

Store at room temperature

INACTIVE INGREDIENT

Light mineral oil, White petrolatum

FIRST AID ANTIBIOTIC

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

S-OINT BACITRACIN 
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-016-30	1 in 1 CARTON	04/01/2021	02/08/2023
1		30 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	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-016)

Revised: 2/2023

Document Id: f42b38b2-1cf8-bfdd-e053-2a95a90a1477

34390-5

Set id: c02288ab-50e3-4385-abaf-33a001a816b4

Version: 2

Effective Time: 20230208