FDA.reportPublic FDA data

Vitamin A D

Manufacturer
Dynarex Corporation | Sion Biotext Mexico SAPI de CV
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:52:24

Label at a glance#

ProductVitamin A 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 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

Storage and handling

Store at room temperature 15°-30°C (59° - 86°F) Avoid excessive heat and humidity Tamper Evident. Do not use if packet is torn, cut or opened

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP 93% 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 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

When using this product

OTC - WHEN USING SECTION

Do not get into eyes

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • The condition persists or gets worse
  • 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

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Other information:

STORAGE AND HANDLING SECTION

  • Store at room temperature 15°-30°C (59° - 86°F)
  • Avoid excessive heat and humidity
  • Tamper Evident. Do not use if packet is torn, cut or opened

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67777-215-01

Vitamins A & D Ointment

Diaper Rash Ointment

Skin Protectant

144 Packets

Net Wt 5 grams

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1440181petrolatum 93 % Topical OintmentPSN4
1440181petrolatum 0.93 MG/MG Topical OintmentSCD4
1440181petrolatum 93 % Topical OintmentSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67777-215-012025-01-30C16284748780-19d75b9d0-db5b-f424-e053-dadaa90a57ceVitamin A D
67777-215-012020-04-28C16284748780-19d75b9d0-db5b-f424-e053-dadaa90a57ceVitamin A D
67777-215-012020-01-31C16284748780-19d75b9d0-db5b-f424-e053-dadaa90a57ceVitamin A D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-215-01Vitamin A D5 g in 1 PACKETOINTMENT54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-215VITAMIN A D (PETROLATUM) OINTMENT [DYNAREX CORPORATION]4Current NDC, Legacy NDC, 1 package rows20221213_4711232c-31a8-4a2c-b2a3-cb53030c4bc0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-215-01GM - Gram67777-2150ec868f7-1bb6-4b66-b5f6-0bf38e7a85a212021-07-15
67777-215-07GM - Gram67777-215e8421c5f-297e-4d4d-bdfe-2587fd7e3c8612023-01-09
67777-215-08GM - Gram67777-2150c696992-3df2-4aa9-9f64-0d68227e082f12023-01-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF411
LANOLININACTIVE INGREDIENT7EV65EAW6H1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-21567777-215-01

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
VITAMIN A PALMITATE1D1K0N0VVCIACT
CHOLECALCIFEROL1C6V77QF41IACT
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 · 4 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
2 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
2 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A DPETROLATUMDynarex Corporationdb4df818-cb0c-434d-e053-2a95a90aaa192025-12-18WarningsExact identifier
ndc (product): 67777-215
efa748d5-20ba-2101-e053-2a95a90adcf64711232c-31a8-4a2c-b2a3-cb53030c4bc02022-12-12WarningsExact identifier
spl id: efa748d5-20ba-2101-e053-2a95a90adcf6
spl set id: 4711232c-31a8-4a2c-b2a3-cb53030c4bc0

Reported adverse events (FAERS/openFDA)#

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