bacitraycin plus

Manufacturer
First Aid Research Corp
Effective date
2020-10-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:31:14

Label at a glance#

Productbacitraycin plus
Active ingredientPRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC
Label structure13 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each gram) Purposes

Bacitracin zinc 500 units............First aid antibiotic

Parmoxine HCl 10 mg...............External analgesic

OTC - PURPOSE SECTION

Uses

  • first aid to help prevent infection and for the temporary relief of pain in minor:
  • cuts
  • scrapes
  • burns

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do no use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body or bandage

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

  • you need to use longer than 1 week
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • condition persists or gets worse
  • redness, irritation, swelling, or pain persists or increases
  • rash or other allergic reactin develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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 (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

  • adults and children 2 years of age and older:
  • 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
  • children under 2 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients aloe vera oil, petrolatum

DOSAGE & ADMINISTRATION SECTION

Dirtributed by:

FIRST AID RESEARCH CORP.

Jupiter, FL 33478 Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncartoncartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1303727bacitracin 500 UNT / pramoxine HCl 10 MG per GM Topical OintmentPSN7
1303727bacitracin 0.5 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD7
1303727bacitracin 500 UNT / pramoxine hydrochloride 10 MG per GM Topical OintmentSY7

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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75983-056-01bacitraycin plus28 g in 1 TUBEOINTMENT287
75983-056-01bacitraycin plus1 in 1 BOXOINTMENT17
75983-056-02bacitraycin plus28 g in 1 TUBEOINTMENT287
75983-056-02bacitraycin plus1 in 1 BOXOINTMENT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75983-056BACITRAYCIN PLUS (BACITRACIN ZINC AND PRAMOXINE HYDROCHLORIDE) OINTMENT [FIRST AID RESEARCH CORP]7Legacy NDC, 4 package rows20201009_7f232729-a442-fd8b-e053-2991aa0adf9e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75983-05675983-056-01, 75983-056-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
b12d0907-b8fe-ec3c-e053-2a95a90a513d7f232729-a442-fd8b-e053-2991aa0adf9e2020-10-08WarningsExact identifier
spl id: b12d0907-b8fe-ec3c-e053-2a95a90a513d
spl set id: 7f232729-a442-fd8b-e053-2991aa0adf9e

Reported adverse events (FAERS/openFDA)#

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