FDA.reportPublic FDA data

Gerigentle-Vitamins A and D

Manufacturer
AG INTERNATIONAL
Effective date
2021-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:53

Label at a glance#

ProductGerigentle-Vitamins A and D
Active ingredientPETROLATUM
Label structure9 sections

Indications and uses

Helps treat and prevent diaper rash Helps seal out wetness Temporarily protects minor cuts scrapes burns Temporarily helps protect and relieve chapped and cracked skin or 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 wetness ma...

Dosage and administration

change wet and soiled diaper promptly cleanse the diaper area and allow to dry apply as needed

Storage and handling

store at 15°-30°C (59°-86°F) avoid excessive heat and humidity

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 relieve chapped and cracked skin or 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 wetness 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 consult a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days
  • symptoms clear up and reoccur in a few days

Do not use on

OTC - DO NOT USE SECTION

  • deep puncture wounds
  • animal bites
  • serious burns

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 immediately

Directions for use with Diaper Rash

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diaper promptly
  • cleanse the diaper area and allow to dry
  • apply as needed

Other information

STORAGE AND HANDLING SECTION

  • store at 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A and Vitamin D

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelpacket labelpacket labeltubes labeltubes label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1440181petrolatum 93 % Topical OintmentPSN3
1440181petrolatum 0.93 MG/MG Topical OintmentSCD3
1440181petrolatum 93 % Topical OintmentSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73235-1053-22022-07-29C16284748780-1c7ccaba7-19a7-fd44-e053-dadaa90aa01bGerigentle-Vitamins A and D
73235-1053-32022-07-29C16284748780-1c7ccaba7-19a7-fd44-e053-dadaa90aa01bGerigentle-Vitamins A and D
73235-1053-42022-07-29C16284748780-1c7ccaba7-19a7-fd44-e053-dadaa90aa01bGerigentle-Vitamins A and D
73235-1053-22021-11-10C16284748780-1c7ccaba7-19a7-fd44-e053-dadaa90aa01bGerigentle-Vitamins A and D
73235-1053-32021-11-10C16284748780-1c7ccaba7-19a7-fd44-e053-dadaa90aa01bGerigentle-Vitamins A and D
73235-1053-42021-11-10C16284748780-1c7ccaba7-19a7-fd44-e053-dadaa90aa01bGerigentle-Vitamins A and D
73235-1053-22021-07-23C16284748780-1c7ccaba7-19a7-fd44-e053-dadaa90aa01bGerigentle-Vitamins A and D
73235-1053-32021-07-23C16284748780-1c7ccaba7-19a7-fd44-e053-dadaa90aa01bGerigentle-Vitamins A and D
73235-1053-42021-07-23C16284748780-1c7ccaba7-19a7-fd44-e053-dadaa90aa01bGerigentle-Vitamins A and D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73235-1053-2Gerigentle-Vitamins A and D5 g in 1 PACKETOINTMENT53
73235-1053-3Gerigentle-Vitamins A and D12 in 1 CARTONOINTMENT123
73235-1053-3Gerigentle-Vitamins A and D113 g in 1 TUBEOINTMENT1133
73235-1053-4Gerigentle-Vitamins A and D5 g in 1 PACKETOINTMENT53
73235-1053-4Gerigentle-Vitamins A and D144 in 1 BOXOINTMENT1443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73235-1053GERIGENTLE-VITAMINS A AND D (PETROLATUM) OINTMENT [AG INTERNATIONAL]3Legacy NDC, 5 package rows20211112_a0c1b244-5f30-21fb-e053-2995a90a6211.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
73235-105373235-1053-3, 73235-1053-2, 73235-1053-4

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
LANOLIN7EV65EAW6HIACT
LAVENDER OILZBP1YXW0H8IACT
LIGHT MINERAL OILN6K5787QVPIACT
VITAMIN A81G40H8B0TIACT
VITAMIN D9VU1KI44GPIACT
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

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
d0756602-82dc-a997-e053-2995a90ab7d2a0c1b244-5f30-21fb-e053-2995a90a62112021-11-10WarningsExact identifier
spl id: d0756602-82dc-a997-e053-2995a90ab7d2
spl set id: a0c1b244-5f30-21fb-e053-2995a90a6211

Reported adverse events (FAERS/openFDA)#

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