FDA.reportPublic FDA data

S-Oint ANTISEPTIC OINTMENT

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:34

Label at a glance#

ProductS-Oint ANTISEPTIC
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and uses

First aid to help prevent infection in • Minor Cuts • Scrapes • Burns

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

PURPOSE

OTC - PURPOSE SECTION

First aid antiseptic

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

USES:

INDICATIONS & USAGE SECTION

First aid to help prevent infection in • Minor Cuts • Scrapes • Burns

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic1Antiseptic1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-021-302023-02-08C16284748780-1f386c649-b6a9-0266-e053-dadaa90a7c1aS-Oint ANTISEPTIC OINTMENT
73921-021-302023-01-30C16284748780-1f386c649-b6a9-0266-e053-dadaa90a7c1aS-Oint ANTISEPTIC OINTMENT

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-02173921-021-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE-IODINE85H0HZU99MACTIM
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
PEG-50 STEARATE776CJK5X56IACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM IODATEI139E44NHLIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f42b2912-2498-7619-e053-2a95a90ae1ba64c46ae9-3b3c-4b1c-a6be-c8aea17f313b2023-02-08WarningsExact identifier
spl set id: 64c46ae9-3b3c-4b1c-a6be-c8aea17f313b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.