FDA.reportPublic FDA data

A&D+E Ointment

Manufacturer
Gentell, Inc.
Effective date
2024-08-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:16:59

Label at a glance#

ProductA and D plus E
Active ingredientPETROLATUM
Label structure9 sections

Storage and handling

Other information store between 20ºC to 25ºC (68ºF to 77ºF) avoid direct sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 99.85%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

temporarily protects minor:

  • cuts
  • scrapes
  • burns

temporarily protects and helps relieve chapped, chafed, or cracked skin and lips

helps protect from the drying effects of wind and cold weather

WARNINGS SECTION

Warnings

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor if

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

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

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

OTC - DO NOT USE SECTION

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

For external use only

If swallowed, get medical help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE SECTION

Directions

  • apply as needed

DOSAGE & ADMINISTRATION SECTION

apply as needed

STORAGE AND HANDLING SECTION

Other information

store between 20ºC to 25ºC (68ºF to 77ºF)

avoid direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients

medium chain triglyceride oil, vitamin A palmitate, vitamin D 3, vitamin E (alpha-tocopherol)

OTC - QUESTIONS SECTION

Questions?

Call 800-840-9041 Monday through Friday 9:00 AM to 5:00 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentell We make it better

GEN-23450

A&D+E Ointment

Skin Protectant

13 oz. (369 g)

Gentell 104 Shorting Rd., Toronto, ON,Canada, M1S3S4 www.gentell.com

A&D+E OintmentA&D+E Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1302906petrolatum 99.9 % Topical OintmentPSN5
1302906petrolatum 0.999 MG/MG Topical OintmentSCD5
1302906petrolatum 99.85 % Topical OintmentSY5
1302906petrolatum 99.89 % Topical OintmentSY5
1302906petrolatum 99.9 % Topical OintmentSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61554-200-012025-07-29C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-022025-07-29C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-032025-07-29C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-042025-07-29C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-052025-07-29C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-062025-07-29C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-012024-08-08C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-022024-08-08C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-032024-08-08C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-042024-08-08C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-052024-08-08C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-062024-08-08C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-012022-01-28C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-022022-01-28C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-032022-01-28C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-042022-01-28C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-052022-01-28C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment
61554-200-062022-01-28C16284748780-1d6a99b39-652e-a426-e053-dadaa90af4c2A&D+E Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61554-200-01A and D plus E56.7 g in 1 TUBEOINTMENT56.75
61554-200-02A and D plus E113.4 g in 1 TUBEOINTMENT113.45
61554-200-03A and D plus E368.5 g in 1 JAROINTMENT368.55
61554-200-04A and D plus E453.6 g in 1 JAROINTMENT453.65
61554-200-05A and D plus E567 g in 1 JAROINTMENT5675
61554-200-06A and D plus E5 g in 1 PACKETOINTMENT55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61554-200A AND D PLUS E (VITAMIN A, D, AND E OINTMENT) OINTMENT [GENTELL, INC.]5Legacy NDC, 6 package rows20240809_9b804a84-0b1b-33a8-e053-2a95a90a19ee.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-20061554-200-01, 61554-200-02, 61554-200-03, 61554-200-04, 61554-200-05, 61554-200-06

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
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PETROLATUM4T6H12BN9UACTIB
VITAMIN A PALMITATE1D1K0N0VVCIACT
VITAMIN D9VU1KI44GPIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT

Source Document#

Source XML · Source PDF

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
1f310fb1-185d-b467-e063-6294a90a72fe9b804a84-0b1b-33a8-e053-2a95a90a19ee2024-08-08WarningsExact identifier
spl id: 1f310fb1-185d-b467-e063-6294a90a72fe
spl set id: 9b804a84-0b1b-33a8-e053-2a95a90a19ee

Reported adverse events (FAERS/openFDA)#

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