FDA.reportPublic FDA data

Galentic Vitamin A D

Manufacturer
Galentic Pharma (India) Priva Te Limited
Effective date
2013-08-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:36:29

Label at a glance#

ProductGalentic Vitamin A D
Active ingredientPETROLATUM
Label structure11 sections

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

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

Stop use and ask a doctor if:

DOSAGE & ADMINISTRATION SECTION

  • 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.

Directions for diaper rash:

INDICATIONS & USAGE 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: Light Liquid Parafin, Vitamin A, Vitamin D

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Galentic Vit AD.jpg

Galentic Vit ADGalentic Vit AD

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049072petrolatum 76 % Topical OintmentPSN2
1049072petrolatum 0.76 MG/MG Topical OintmentSCD2
1049072petrolatum 76 % Topical OintmentSY2

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
50382-003-012019-11-27C16284748780-19855d018-e18c-cd31-e053-dbdaa90ab51aGalentic Vitamin A D
50382-003-022019-11-27C16284748780-19855d018-e18c-cd31-e053-dbdaa90ab51aGalentic Vitamin A D
50382-003-032019-11-27C16284748780-19855d018-e18c-cd31-e053-dbdaa90ab51aGalentic Vitamin A D
50382-003-042019-11-27C16284748780-19855d018-e18c-cd31-e053-dbdaa90ab51aGalentic Vitamin A D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50382-003-01Galentic Vitamin A D113.4 g in 1 TUBEOINTMENT113.42
50382-003-02Galentic Vitamin A D425.25 g in 1 JAROINTMENT425.252
50382-003-03Galentic Vitamin A D28.35 g in 1 TUBEOINTMENT28.352
50382-003-04Galentic Vitamin A D56.7 g in 1 TUBEOINTMENT56.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50382-003GALENTIC VITAMIN A D (PETROLATUM) OINTMENT [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]2Legacy NDC, 4 package rows20130808_a56cf1f3-e64a-455c-ac8e-22403970cb0f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF412
LANOLININACTIVE INGREDIENT7EV65EAW6H2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2

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
50382-00350382-003-01, 50382-003-02, 50382-003-03, 50382-003-04

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
PETROLATUM4T6H12BN9UACTIB
VITAMIN A PALMITATE1D1K0N0VVCIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
CHOLECALCIFEROL1C6V77QF41IACT

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 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / AURICULAR (OTIC)419 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM, AUGMENTED / TOPICAL25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPFILM, EXTENDED RELEASE / TRANSDERMAL162 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCAPSULE / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET / ORAL7.5 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSUPPOSITORY / VAGINAL1464.9 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTILLE / ORAL3.6 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSYSTEM / TRANSDERMAL170 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, COATED / ORAL4.8 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTE / DENTAL687 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii candidate
19 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
ac08d733-4b4a-4721-b701-5c8444aafc8da56cf1f3-e64a-455c-ac8e-22403970cb0f2013-08-08WarningsExact identifier
spl id: ac08d733-4b4a-4721-b701-5c8444aafc8d
spl set id: a56cf1f3-e64a-455c-ac8e-22403970cb0f

Reported adverse events (FAERS/openFDA)#

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