FDA.reportPublic FDA data

Triple Antibiotic Plus Pain Relief Maximum Strength Ointment - Freds

Manufacturer
Freds Inc
Effective date
2019-11-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:00:19

Label at a glance#

ProductTriple Antibiotic Plus Pain Relief Maximum Strength
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

First aid to help prevent infection and for temporary relief of pain or discomfort due to minor cuts scrapes burns

Dosage and administration

Adults and children 2 years and older: clean 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 Children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

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

Purposes

OTC - PURPOSE SECTION

First aid antibiotic/Pain reliever

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection and for temporary relief of pain or discomfort due to

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

SPL UNCLASSIFIED SECTION

  • do not use if allergic to any of the ingredients

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition perists or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older:

  • clean 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

Children under 2 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Store at 59°-86°F (15°-30°C).
  • Before using any medication, read all label directions. Keep carton, it contains important information

Inactive ingredient

INACTIVE INGREDIENT SECTION

white petrolatum

Questions?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fred's Pharmacy

NDC 55315-823-34
HELPS PREVENT INFECTION IN
MINOR CUTS, SCRAPES & BURNS

MAXIMUM STRENGTH
TRIPLE ANTIBIOTIC + PAIN RELIEF
(BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE-PRAMOXINE HCL)

FIRST AID ANTIBIOTIC/PAIN RELIEVING OINTMENT

NET WT ½ OZ (14g)

Compare To The Active Ingredients In:
*Neosporin® + Pain Relief

Triple Antibiotic + Pain Relief
Triple Antibiotic + Pain Relief

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266931
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D41
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L51
BACITRACINACTIVE MOIETY58H6RWO52I1
NEOMYCINACTIVE MOIETYI16QD7X2971
POLYMYXIN BACTIVE MOIETYJ2VZ07J96K1
PRAMOXINEACTIVE MOIETY068X84E0561
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1

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
55315-82355315-823-34

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates

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
234fbba9-678c-45d8-b9b7-82e7d7e0f366fbc3f6c2-07ca-4deb-a238-92c49e3984f22019-11-20WarningsExact identifier
spl id: 234fbba9-678c-45d8-b9b7-82e7d7e0f366
spl set id: fbc3f6c2-07ca-4deb-a238-92c49e3984f2

Reported adverse events (FAERS/openFDA)#

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