FDA.reportPublic FDA data

Jell Pharmaceuticals Vitamin A D

Manufacturer
Jell Pharmaceuticals Pvt. Ltd. | jell pharmaceuticals pvt.ltd
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:44:14

Label at a glance#

ProductJell Pharmaceuticals Vitamin A D
Active ingredientPETROLATUM
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                               Purpose

White Petrolatum USP (76%)            Skin Protectant

Purpose:

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

When using this product:

OTC - WHEN USING SECTION

  • Do not get in eyes

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Stop use and ask a doctor if:

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

Do not use:

OTC - DO NOT USE SECTION

Do not use:

  • 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.

Indications & Usage

INDICATIONS & USAGE SECTION

Directions 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 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: Light Liquid Parafin, Vitamin A, Vitamin D

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jell Vit AD.jpg

Jell Vit ADJell Vit AD

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049072petrolatum 76 % Topical OintmentPSN3
1049072petrolatum 0.76 MG/MG Topical OintmentSCD3
1049072petrolatum 76 % Topical OintmentSY3

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
30400-214-012020-07-28C16284748780-19d75b9d0-4f75-f424-e053-dadaa90a57ceVitamin A D
30400-214-022020-07-28C16284748780-19d75b9d0-4f75-f424-e053-dadaa90a57ceVitamin A D
30400-214-032020-07-28C16284748780-19d75b9d0-4f75-f424-e053-dadaa90a57ceVitamin A D
30400-214-042020-07-28C16284748780-19d75b9d0-4f75-f424-e053-dadaa90a57ceVitamin A D
30400-214-012020-01-31C16284748780-19d75b9d0-4f75-f424-e053-dadaa90a57ceVitamin A D
30400-214-022020-01-31C16284748780-19d75b9d0-4f75-f424-e053-dadaa90a57ceVitamin A D
30400-214-032020-01-31C16284748780-19d75b9d0-4f75-f424-e053-dadaa90a57ceVitamin A D
30400-214-042020-01-31C16284748780-19d75b9d0-4f75-f424-e053-dadaa90a57ceVitamin A D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30400-214-01Jell Pharmaceuticals Vitamin A D113.4 g in 1 TUBEOINTMENT113.43
30400-214-02Jell Pharmaceuticals Vitamin A D425.25 g in 1 JAROINTMENT425.253
30400-214-03Jell Pharmaceuticals Vitamin A D28.35 g in 1 TUBEOINTMENT28.353
30400-214-04Jell Pharmaceuticals Vitamin A D56.7 g in 1 TUBEOINTMENT56.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30400-214JELL PHARMACEUTICALS VITAMIN A D (PETROLATUM) OINTMENT [JELL PHARMACEUTICALS PVT. LTD.]3Current NDC, Legacy NDC, 4 package rows20241219_6ab8ba54-3679-4fd0-a876-cb89aace96ca.zip

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
30400-21430400-214-01, 30400-214-02, 30400-214-03, 30400-214-04

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
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
CHOLECALCIFEROL1C6V77QF41IACT
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 · 10 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
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
5 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
Jell Pharmaceuticals Vitamin A DPETROLATUMJell Pharmaceuticals Pvt. Ltd.6ab8ba54-3679-4fd0-a876-cb89aace96ca2024-12-17WarningsExact identifier
ndc (package): 30400-214-01
ndc (package): 30400-214-02
ndc (package): 30400-214-03
ndc (package): 30400-214-04
ndc (product): 30400-214
ndc11 (package): 30400021402
ndc11 (package): 30400021404
ndc11 (package): 30400021403
ndc11 (package): 30400021401
spl id: 2974f712-dadd-bbff-e063-6294a90a8d84
spl set id: 6ab8ba54-3679-4fd0-a876-cb89aace96ca

Reported adverse events (FAERS/openFDA)#

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