FDA.reportPublic FDA data

Vitastem ULTRA

Manufacturer
ViaDerma Distribution, Inc
Effective date
2025-04-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:43:44

Label at a glance#

ProductVitastem ULTRA
Active ingredientBACITRACIN ZINC
Label structure8 sections

Indications and uses

First aid to help prevent the risk of skin infection in minor cuts, scrapes, or 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 this product is an OTC antibiotic for human use contains no alcohol, no animal ingredients blended for typical skin color no claims regarding stem cell healing are implied for this product Stop use if product is misused

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (500 units Bacitracin in 1g)

Purpose

OTC - PURPOSE SECTION

First Aid/Antibiotic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.

Warnings

WARNINGS SECTION

For external use only. May be harmful if swallowed.

Allergy Alert

Do not use if allergic to any ingredients in VitaStem™ ULTRA.

Do not use

OTC - DO NOT USE SECTION

  • in eyes
  • over large areas of the body
  • longer than 1 week unless directed by doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or punture wounds 
  • animal bites
  • serious trauma

Stop use and ask a doctor if 

OTC - STOP USE SECTION

condition persists or gets worse.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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
  • this product is an OTC antibiotic for human use
  • contains no alcohol, no animal ingredients
  • blended for typical skin color
  • no claims regarding stem cell healing are implied for this product

Stop use if product is misused

Other Information

SPL UNCLASSIFIED SECTION

  • store in a cool dry place

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl cellulose, magnesium stearate, sodium hydroxide, sorbic acid, stearic acid, water

Package Labeling:71262-007-15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

Package Labeling:71262-007-55

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN4
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD4
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71262-007-15Vitastem ULTRA1 in 1 CARTONOINTMENT14
71262-007-15Vitastem ULTRA15 mL in 1 BOTTLEOINTMENT154
71262-007-55Vitastem ULTRA55 mL in 1 BOTTLEOINTMENT554
71262-007-55Vitastem ULTRA1 in 1 CARTONOINTMENT14

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71262-00771262-007-15, 71262-007-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETIC ACIDQ40Q9N063PIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
CHOLECALCIFEROL1C6V77QF41IACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
HISTIDINE4QD397987EIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBIC ACIDX045WJ989BIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
BACITRACIN ZINC89Y4M234ESACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-03-14full-release2026-06-01 00:57:24

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982f41ea6bd6efb…

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
Vitastem ULTRABACITRACIN ZINCViaDerma Distribution, Incfd96cc09-8522-44a5-b034-0d30e532410d2025-04-03WarningsExact identifier
ndc (package): 71262-007-55
ndc (package): 71262-007-15
ndc (product): 71262-007
ndc11 (package): 71262000755
ndc11 (package): 71262000715
spl id: 31e66bc1-9658-d154-e063-6394a90a708a
spl set id: fd96cc09-8522-44a5-b034-0d30e532410d

Reported adverse events (FAERS/openFDA)#

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