FDA.reportPublic FDA data

Gerigentle-Bacitracin zinc

Manufacturer
Geri-Gentle Corporation
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:40:17

Label at a glance#

ProductGerigentle-Bacitracin zinc
Active ingredientBACITRACIN ZINC
Label structure9 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 1-3 times daily (an amount equal to the surface area of a fingertip) May be covered with a sterile bandage

Storage and handling

Store at 15°-30°C (59°-86°F) Avoid excessive heat and humidity

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (In each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc (equal to 500 Bacitracin Units)

Purpose

OTC - PURPOSE SECTION

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

Do Not Use

OTC - DO NOT USE SECTION

  • In the eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 7 days unless directed by a physician

Consult a doctor before use in cases of

OTC - ASK DOCTOR SECTION

  • Deep or puncture wounds
  • Animal Bites
  • Serious Burns

Stop usage and consult a doctor if

OTC - STOP USE SECTION

  • Conditions persist or get worse
  • Rash or other allergic reaction develops

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 immediately

Directions for Use

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Apply a small amount of this product 1-3 times daily (an amount equal to the surface area of a fingertip)
  • May be covered with a sterile bandage

Other information

STORAGE AND HANDLING SECTION

  • Store at 15°-30°C (59°-86°F)
  • Avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hard Paraffin, Liquid Paraffin, White Soft Paraffin and Lanolin

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN7
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD7
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY7

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130648289160758GTIN-13: 0648289160758
EAN-13: 0648289160758
GTIN-12: 648289160758
UPC-A: 648289160758
GTIN storage (14 digits): 00648289160758		bacitracin.jpg

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
69771-106-342025-01-06C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-342025-01-06C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-352025-01-06C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-352025-01-06C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-342023-01-30C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-342023-01-30C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-352023-01-30C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-352023-01-30C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-342020-02-06C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-342020-02-06C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-352020-02-06C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-352020-02-06C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-342020-01-31C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-342020-01-31C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-352020-01-31C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc
69771-106-352020-01-31C16284748780-19d75b9d1-1887-f424-e053-dadaa90a57ceGerigentle-Bacitracin zinc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-106-34Gerigentle-Bacitracin zinc0.9 g in 1 PACKETOINTMENT0.97
69771-106-34Gerigentle-Bacitracin zinc144 in 1 BOXOINTMENT1447
69771-106-35Gerigentle-Bacitracin zinc28 g in 1 TUBEOINTMENT287
69771-106-35Gerigentle-Bacitracin zinc1 in 1 CARTONOINTMENT17

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-10669771-106-34, 69771-106-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
MINERAL OILT5L8T28FGPIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
LANOLIN7EV65EAW6HIACT
BACITRACIN ZINC89Y4M234ESACTIM

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-01-06full-release2026-06-01 00:50:58

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
Gerigentle-Bacitracin zincBACITRACIN ZINCGeri-Gentle Corporation7e36e4d0-eac3-4aa3-81a7-e21c224b1cd42025-10-23WarningsExact identifier
ndc (package): 69771-106-35
ndc (package): 69771-106-34
ndc (product): 69771-106
ndc11 (package): 69771010635
ndc11 (package): 69771010634
spl id: 41d61178-65a8-9310-e063-6394a90a5f5e
spl set id: 7e36e4d0-eac3-4aa3-81a7-e21c224b1cd4

Reported adverse events (FAERS/openFDA)#

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