AG INTERNATIONAL

Manufacturer
AG International
Effective date
2019-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:55

Label at a glance#

ProductAG INTERNATIONAL Vitamin A and D
Active ingredientPETROLATUM
Label structure12 sections

Indications and uses

■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect from the drying effects of wind and cold weather ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash ■ with each diaper change, espicially at bedtime when ex...

Dosage and administration

for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP (76% w/w)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

■ helps treat and prevent diaper rash ■ helps seal out wetness ■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily helps protect and relieve chapped and cracked skin or lips ■ helps prevent and protect from the drying effects of wind and cold weather ■ helps prevent and protect chafed skin or minor skin irritations associated with diaper rash ■ with each diaper change, espicially at bedtime when exposure to wet diapers may be prolonged

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

■ do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days

Do not use on

OTC - DO NOT USE SECTION

■ animal bites ■ deep or puncture wounds ■ serious burns

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

Directions

DOSAGE & ADMINISTRATION SECTION

for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply as needed

Other Information

SPL UNCLASSIFIED SECTION

■ store at 59-86F (15-30C) ■ avoid excessive heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

lanolin, lavender oil, light liquid paraffin, vitamin A, vitamin D

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug fact PanelDrug fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049072petrolatum 76 % Topical OintmentPSN1
1049072petrolatum 0.76 MG/MG Topical OintmentSCD1
1049072petrolatum 76 % Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73235-3045-22021-01-29C16284748780-1ba0f9c33-4575-a910-e053-dadaa90a0b85VITAMIN A N D MED
73235-3045-32021-01-29C16284748780-1ba0f9c33-4575-a910-e053-dadaa90a0b85VITAMIN A N D MED
73235-3045-42021-01-29C16284748780-1ba0f9c33-4575-a910-e053-dadaa90a0b85VITAMIN A N D MED
73235-3045-52021-01-29C16284748780-1ba0f9c33-4575-a910-e053-dadaa90a0b85VITAMIN A N D MED

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73235-3045-2AG INTERNATIONALVitamin A and D5 g in 1 PACKETOINTMENT51
73235-3045-3AG INTERNATIONALVitamin A and D28.3 g in 1 TUBEOINTMENT28.31
73235-3045-4AG INTERNATIONALVitamin A and D113 g in 1 TUBEOINTMENT1131
73235-3045-5AG INTERNATIONALVitamin A and D425 g in 1 JAROINTMENT4251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73235-3045AG INTERNATIONAL VITAMIN A AND D (WHITE PETROLATUM) OINTMENT [AG INTERNATIONAL]1Legacy NDC, 4 package rows20190724_8e104ed7-0902-3e22-e053-2a95a90ac1c9.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73235-304573235-3045-2, 73235-3045-3, 73235-3045-4, 73235-3045-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
8e110ca3-4aa2-577d-e053-2995a90ad2948e104ed7-0902-3e22-e053-2a95a90ac1c92019-07-23WarningsExact identifier
spl id: 8e110ca3-4aa2-577d-e053-2995a90ad294
spl set id: 8e104ed7-0902-3e22-e053-2a95a90ac1c9

Reported adverse events (FAERS/openFDA)#

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