FDA.reportPublic FDA data

CVS Health Triple Antibiotic with Pain Relief

Manufacturer
CVS Health | Sheffield Pharmaceuticals LLC
Effective date
2024-11-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:36:41

Label at a glance#

ProductCVS Health Triple Antibiotic with Pain Relief
Active ingredientBacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, PRAMOXINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

helps prevent infection in and temporarily relieves pain due to minor: cuts scrapes burns

Dosage and administration

clean the affected area apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily. may be covered with a sterile bandage

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine HCL 10 mg 

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain Relief 

Uses

INDICATIONS & USAGE SECTION

helps prevent infection in and temporarily relieves pain due to minor:

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

SPL UNCLASSIFIED SECTION

  • do not use if you are allergic to any of the ingredients

Do not use

OTC - DO NOT USE SECTION

  • in or near the eyes
  • on large areas of the body

Consult 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

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • condition persists 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
  • may be covered with a sterile bandage

Other information

SPL UNCLASSIFIED SECTION

  • Store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive ingredient

INACTIVE INGREDIENT SECTION

Petrolatum

Principal Display Panel – Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Packet LabelPrincipal Display Panel – Packet Label

CVS Health  NDC 69842-161-10

Triple Antibiotic Ointment & Pain Relief Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate• Pramoxine HCL 
First Aid Antibiotic/Pain relieving Ointment 

NET WT. 0.03 oz. (0.9g)

Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton LabelPrincipal Display Panel – Carton Label

CVS Health NDC 69842-161-10

Triple Antibiotic & Pain Relief Ointment 

Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate•Pramoxine HCL
First Aid Antibiotic /Pain relieving Ointment

24 packets 

NET WT. 0.72 oz. (20.4g)
First Aid Treatment for Minor Cuts, Scrapes and Burns

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-161CVS HEALTH TRIPLE ANTIBIOTIC WITH PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE AND PRAMOXINE HCL) OINTMENT [CVS HEALTH]3Legacy NDC20241113_4c60b0a2-2f6f-4ded-9d6f-96fb1f40bbd4.zip

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
69842-16169842-161-10

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
Polymyxin B Sulfate19371312D4ACTIM
Neomycin Sulfate057Y626693ACTIM
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
Petrolatum4T6H12BN9UIACT

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
2d620e52-77e7-48cc-a0e8-76a0585d5b294c60b0a2-2f6f-4ded-9d6f-96fb1f40bbd42024-11-11WarningsExact identifier
spl id: 2d620e52-77e7-48cc-a0e8-76a0585d5b29
spl set id: 4c60b0a2-2f6f-4ded-9d6f-96fb1f40bbd4

Reported adverse events (FAERS/openFDA)#

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