FDA.reportPublic FDA data

S-Oint BACITRACIN OINTMENT FIRST AID ANTIBIOTIC

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 22:47:51

Label at a glance#

ProductS-Oint BACITRACIN
Active ingredientBACITRACIN
Label structure10 sections

Indications and uses

Helps prevent infection in minor cuts, scrapes and burns

Dosage and administration

• 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

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Bacitracin 500 units

PURPOSE

OTC - PURPOSE SECTION

First aid antibiotic

USES

INDICATIONS & USAGE SECTION

Helps prevent infection in minor cuts, scrapes and burns

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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?

OTC - QUESTIONS SECTION

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

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Light mineral oil, White petrolatum

SPL UNCLASSIFIED SECTION

FIRST AID ANTIBIOTIC

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

Soint-16Soint-16

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-016-302023-02-08C16284748780-1f386c64a-475d-0266-e053-dadaa90a7c1aS-Oint BACITRACIN OINTMENT FIRST AID ANTIBIOTIC
73921-016-302023-01-30C16284748780-1f386c64a-475d-0266-e053-dadaa90a7c1aS-Oint BACITRACIN OINTMENT FIRST AID ANTIBIOTIC

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-01673921-016-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACITRACIN58H6RWO52IACTIB
LIGHT MINERAL OILN6K5787QVPIACT
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
f42b38b2-1cf8-bfdd-e053-2a95a90a1477c02288ab-50e3-4385-abaf-33a001a816b42023-02-08WarningsExact identifier
spl set id: c02288ab-50e3-4385-abaf-33a001a816b4

Reported adverse events (FAERS/openFDA)#

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