FDA.reportPublic FDA data

BACITRACIN ZINC - OL PHARMA TECH, LLC Drs PHARMACY

Manufacturer
OL PHARMA TECH, LLC Drs PHARMACY
Effective date
2026-07-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-17 21:45:40

Label at a glance#

ProductDrs. Pharmacy Triple Antibiotic Plus Pain relief
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

first aid to help prevent infection in minor • cuts • scrapes • burns

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc 500 units
Neomycin 3.5 mg
Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor
• cuts
• scrapes
• burns

Purpose

OTC - PURPOSE SECTION

  • first aid antibiotic
  • External Analgesic

Do Not Use

OTC - DO NOT USE SECTION

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

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have
• deep or puncture wounds
• animal bites
• serious burns

OTC - STOP USE SECTION

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 REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

• 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

OTHER SAFETY INFORMATION

Store at room temperature

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRIPLE ANTIBIOTIC 2TRIPLE ANTIBIOTIC 2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80489-857-012026-01-29C16284748780-149896155-b8ad-586f-e063-e6dba90add901626fa89-cec0-6467-e063-6294a90aa2a4
80489-857-012026-01-29C16284748780-149896155-b8ad-586f-e063-e6dba90add901626fa89-cec0-6467-e063-6294a90aa2a4
80489-857-022026-01-29C16284748780-149896155-b8ad-586f-e063-e6dba90add901626fa89-cec0-6467-e063-6294a90aa2a4
80489-857-022026-01-29C16284748780-149896155-b8ad-586f-e063-e6dba90add901626fa89-cec0-6467-e063-6294a90aa2a4

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80489-85780489-857-01, 80489-857-02

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
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-04-15full-release2026-06-01 00:11:07

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
Drs. Pharmacy Triple Antibiotic Plus Pain reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACY1626fa89-cec0-6467-e063-6294a90aa2a42026-07-09WarningsExact identifier
ndc (package): 80489-857-01
ndc (package): 80489-857-02
ndc (product): 80489-857
ndc11 (package): 80489085701
ndc11 (package): 80489085702
spl id: 5636791e-1403-2455-e063-6394a90a87fc
spl set id: 1626fa89-cec0-6467-e063-6294a90aa2a4

Reported adverse events (FAERS/openFDA)#

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