FDA.reportPublic FDA data

Vitamin A D

Manufacturer
Dynarex Corporation
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
36
Source
full-release
Hydrated at
2026-06-01 00:38:21

Label at a glance#

ProductVitamin A D
Active ingredientPETROLATUM
Label structure13 sections

Indications and uses

Helps treat and prevent diaper rash Helps seal out wetness Temporarily protects minor * cuts * scrapes * burns Temporarily helps protect and help relieve chapped and cracked skin and 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, especially at bedtime when exposure t...

Dosage and administration

Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply as needed

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                               Purpose

White Petrolatum USP (76%)            Skin Protectant

Uses: Vitamin_A_D

OTC - PURPOSE SECTION

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor * cuts * scrapes * burns
  • Temporarily helps protect and help relieve chapped and cracked skin and 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, especially at bedtime when exposure to wet diapers may be prolonged

Warnings:

WARNINGS SECTION

For External Use Only

Do Not Get In Eyes

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • If 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

Do not use on:

  • Deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

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 for diaper rash:

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed

Other information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
  • Avoid excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A, Vitamin D

Indications and Usage

INDICATIONS & USAGE SECTION

Indications and Usage

A skin protectant for the treatment of diaper rash, minor cuts, scrapes, burns and to help relieve chapped and cracked skin and lips.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1152 IN MASTER1152 IN MASTER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1155 BX MASTER1155 BX MASTER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1157 IN MASTER1157 IN MASTER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049072petrolatum 76 % Topical OintmentPSN36
1049072petrolatum 0.76 MG/MG Topical OintmentSCD36
1049072petrolatum 76 % Topical OintmentSY36

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-214-01Vitamin A D113.4 g in 1 TUBEOINTMENT113.436
67777-214-02Vitamin A D425.25 g in 1 JAROINTMENT425.2536
67777-214-03Vitamin A D12 in 1 CASEOINTMENT1236
67777-214-04Vitamin A D28.35 g in 1 TUBEOINTMENT28.3536
67777-214-05Vitamin A D1 in 1 BOXOINTMENT136
67777-214-06Vitamin A D72 in 1 CASEOINTMENT7236
67777-214-10Vitamin A D6 in 1 BOXOINTMENT636
67777-214-11Vitamin A D72 in 1 CASEOINTMENT7236

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-214VITAMIN A D (PETROLATUM) OINTMENT [DYNAREX CORPORATION]36Current NDC, Legacy NDC, 8 package rows20241122_62ad33f6-46e6-435f-9a5f-e116c3e218bf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-214-01GM - Gram67777-2146346c6d3-78bc-4ff8-b70d-3b5e4740db6e12020-03-10
67777-214-02GM - Gram67777-21487e78232-a968-4ff9-aeb0-3fba40e8b5e412017-12-14
67777-214-03GM - Gram67777-21405214612-9bc3-4428-8a9a-d8459083cb1812023-07-06
67777-214-04GM - Gram67777-2147763d826-f31d-4134-b55e-18889ea9dfdf12022-06-06
67777-214-05GM - Gram67777-214d60d568e-12c1-4af9-8cc4-753f2815ef3812023-07-06
67777-214-06GM - Gram67777-21478e3619e-3e7d-400d-a0f9-a4bd476883ad12023-07-06
67777-214-08GM - Gram67777-214d1ff4800-5611-4600-a9b0-e27c2cf130f312022-06-06
67777-214-10GM - Gram67777-214438c6a6a-1674-4d07-ac82-6b7e992da2e812023-07-06
67777-214-11GM - Gram67777-214f56454eb-640c-461b-b361-5cae7e0eb29612023-07-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U30
PETROLATUMACTIVE MOIETY4T6H12BN9U30
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF4130
LANOLININACTIVE INGREDIENT7EV65EAW6H30
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP30
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC30

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
67777-21467777-214-01, 67777-214-10, 67777-214-11, 67777-214-02, 67777-214-03, 67777-214-04, 67777-214-05, 67777-214-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAVENDER OILZBP1YXW0H8IACT
VITAMIN D9VU1KI44GPIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UACTIB

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
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
9 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
Vitamin A DPETROLATUMDynarex Corporation62ad33f6-46e6-435f-9a5f-e116c3e218bf2024-11-20WarningsExact identifier
ndc (package): 67777-214-05
ndc (package): 67777-214-02
ndc (package): 67777-214-10
ndc (package): 67777-214-03
ndc (package): 67777-214-11
ndc (package): 67777-214-06
ndc (package): 67777-214-01
ndc (package): 67777-214-04
ndc (product): 67777-214
ndc11 (package): 67777021406
ndc11 (package): 67777021401
ndc11 (package): 67777021410
ndc11 (package): 67777021403
ndc11 (package): 67777021402
ndc11 (package): 67777021404
ndc11 (package): 67777021405
ndc11 (package): 67777021411
spl id: 2758a4ca-0038-8353-e063-6294a90ac2da
spl set id: 62ad33f6-46e6-435f-9a5f-e116c3e218bf

Reported adverse events (FAERS/openFDA)#

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