FDA.reportPublic FDA data

CareALL Triple Antibiotic plus Pain Relief

Manufacturer
New World Imports, Inc
Effective date
2019-08-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:11

Label at a glance#

ProductCareALL Triple Antibiotic plus Pain Relief
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5 mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

OTC - PURPOSE SECTION

First aid antibiotic (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5 mg, & Polymyxin B Sulfate 10,000 units)

External Analgesic (Pramoxine HCl 10mg)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center immediately

INDICATIONS & USAGE SECTION

First aid to help prevent infection and for temporary relief of pain in minor cuts, scrapes and burns

WARNINGS SECTION

For external use only

Do not use

In the eyes

If you are allergic to any of the ingredients

Over large areas of the body

Ask a doctor before use if you have

Animal bites

Serious Burns

Deep or puncture wounds

Stop use and ask a doctor if

You need to use longer than 1 week

condition persists or gets worse

rash or other allergic reaction develops

symptoms persist for more than 1 week, or clear up and occur again within a few days

DOSAGE & ADMINISTRATION SECTION

Adults and childre 2 years of age and older:

  • Clean the affected area
  • Apply a small amount of this product (an amount equal to the surface of th 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

INACTIVE INGREDIENT SECTION

White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Plus CartonTriple Plus Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN1
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD1
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
51824-073-012021-01-29C16284748780-1ba0f9c33-50e1-a910-e053-dadaa90a0b85a467b487-74a1-4399-aabe-1dcc7f71b515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-073-01CareALL Triple Antibiotic plus Pain Relief28 g in 1 TUBEOINTMENT281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-073CAREALL TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL) OINTMENT [NEW WORLD IMPORTS, INC]1Legacy NDC, 1 package rows20190902_a467b487-74a1-4399-aabe-1dcc7f71b515.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
51824-07351824-073-01

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

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
74dcb05e-0246-4adc-9e1b-a3de79473d6da467b487-74a1-4399-aabe-1dcc7f71b5152019-08-23WarningsExact identifier
spl id: 74dcb05e-0246-4adc-9e1b-a3de79473d6d
spl set id: a467b487-74a1-4399-aabe-1dcc7f71b515

Reported adverse events (FAERS/openFDA)#

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