S-Oint TRIPLE ANTIBIOTIC OINTMENT

S-Oint TRIPLE ANTIBIOTIC by

Drug Labeling and Warnings

S-Oint TRIPLE ANTIBIOTIC 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 TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate 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 TRIPLE ANTIBIOTIC OINTMENT

Drug Facts

ACTIVE INGREDIENT

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 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 if you are allergic to any of the ingredients

Ask a doctor before use if you have
Serious burns  Deep or puncture wounds  Animal bites

When using this product
Do not use in the eyes
Do not apply over large areas of the body

Stop use and ask a doctor if
You need to use more than 1 week  Condition persists or gets worse  Symptoms persist for more than 1 week or clear up and occur again within a few days.
rash or other allergic reaction develops

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

DIRECTIONS

adults and children 2 years of age or older:
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
children under 2 years of age: ask a doctor

OTHER INFORMATION

Store at 59° to 77°F

INACTIVE INGREDIENTS

Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl / palmitoyl oxostearamide / arachamide MEA, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

Questions or comments?

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

√ First aid ointment √ Helps prevent infection √ Cuts √ Scrapes √ Burns

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

S-OINT TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-018-30	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(73921-018)

Revised: 2/2023

Document Id: f42b2336-f911-6394-e053-2a95a90ac573

34390-5

Set id: c8434954-3507-4851-9382-b1bf2c4442d3

Version: 2

Effective Time: 20230208