FDA.reportPublic FDA data

Wound Ointment

Manufacturer
HEMPFUSION, INC. | Universal Packaging Systems, Inc. (DBA Paklab)
Effective date
2021-03-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:03

Label at a glance#

ProductWound First Aid
Active ingredientBACITRACIN ZINC
Label structure8 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 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 in a cool dry place away from light

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 500 units

Purpose

OTC - PURPOSE SECTION

Bacitracin Zinc 500 units........First aid antibiotic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • on deep or puncture wounds, animal bites, or serious burns

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition persists or gets worse
  • a rash or other allergic reaction develops

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.

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

Other information

STORAGE AND HANDLING SECTION

  • Store in a cool dry place away from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

allantoin, organic shea (butyrospermum parkii) butter, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, cetearyl olivate, organic coconut (cocos nucifera) oil, organic carnauba (copernicia cerifera) wax, organic eucalyptus
(eucalyptus globulus) leaf oil, glycerin, hydrogenated castor oil, organic manuka (leptospermum scoparium) branch oil, magnesium sulfate, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, castor (ricinus communis) seed oil, organic rosemary (rosmarinus officinalis) leaf oil, sorbitan olivate, colloidal silver

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HempFusion

Wound

OINTMENT

First Aid Antibiotic

Bacitracin Zinc USP

BoxBoxLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN3
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD3
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73672-982-102024-01-30C16284748780-11030e365-5774-111a-e063-dadaa90a10e2Wound Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73672-982-10Wound First Aid1 in 1 CARTONOINTMENT13
73672-982-10Wound First Aid10 g in 1 TUBEOINTMENT103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73672-982WOUND FIRST AID (BACITRACIN ZINC 500 UNITS) OINTMENT [HEMPFUSION, INC.]3Legacy NDC, 2 package rows20210319_9ef3b74d-0bd4-35a1-e053-2995a90ac4c6.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73672-98273672-982-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CETEARYL OLIVATE58B69Q84JOIACT
CARNAUBA WAXR12CBM0EIZIACT
MANUKA OILM6QU9ZUH2XIACT
BLACK PEPPER OILU17J84S19ZIACT
CLOVE OIL578389D6D0IACT
CASTOR OILD5340Y2I9GIACT
SILVER3M4G523W1GIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ROSEMARY OIL8LGU7VM393IACT
SORBITAN OLIVATEMDL271E3GRIACT
BACITRACIN ZINC89Y4M234ESACTIB
ALLANTOIN344S277G0ZIACT
SHEA BUTTERK49155WL9YIACT
HEMPTD1MUT01Q7IACT
COCONUT OILQ9L0O73W7LIACT

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
bdc683bb-55ff-89ef-e053-2995a90ac1379ef3b74d-0bd4-35a1-e053-2995a90ac4c62021-03-17WarningsExact identifier
spl id: bdc683bb-55ff-89ef-e053-2995a90ac137
spl set id: 9ef3b74d-0bd4-35a1-e053-2995a90ac4c6

Reported adverse events (FAERS/openFDA)#

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