S-Oint ANTISEPTIC OINTMENT

S-Oint ANTISEPTIC by

Drug Labeling and Warnings

S-Oint ANTISEPTIC 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 ANTISEPTIC- povidone-iodine 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 ANTISEPTIC OINTMENT

Drug Facts

ACTIVE INGREDIENT

Povidone-iodine, 5%
(0.5% available iodine)

PURPOSE

First aid antiseptic

INACTIVE INGREDIENTS

Cetostearyl alcohol, glycerin, Mineral oil, PEG-50 stearate, Polysorbate 60, Potassium iodate, Sodium hydroxide, Sorbitan monostearate, Water, White petrolatum

USES:

First aid to help prevent infection in Minor Cuts Scrapes  Burns

WARNINGS

For external use only

Do not use in the eyes
Over large areas of the body
If you are allergic to povidone-iodine or any other ingredients in this preparation

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

Stop use and ask a doctor if
The condition persists or gets worse
You need to use this product for more than 1 week

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

Questions or comments?

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

DIRECTIONS

Clean the affected area

Apply a small amount of product (equal to the surface area of a fingertip) to the area 1 to 3 times daily

may be covered with a sterile bandage

OTHER INFORMATION

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Helps prevent infections
√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 ANTISEPTIC 
povidone-iodine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-50 STEARATE (UNII: 776CJK5X56)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM IODATE (UNII: I139E44NHL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-021-30	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 not final	part333A	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(73921-021)

Revised: 2/2023

Document Id: f42b2912-2498-7619-e053-2a95a90ae1ba

34390-5

Set id: 64c46ae9-3b3c-4b1c-a6be-c8aea17f313b

Version: 2

Effective Time: 20230208