FDA.reportPublic FDA data

AmeriDerm

Manufacturer
Shield Line LLC
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:46:52

Label at a glance#

ProductAmeriDerm Vitamin 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 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, espicially at bedtime when ex...

Dosage and administration

For Skin Protection and Diaper rash ■ apply as needed Additionally when using for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White petrolatum USP (76% w/w)

Purpose

OTC - PURPOSE SECTION

Skin Protection

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, espicially 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

■ 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

■ 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

For Skin Protection and Diaper rash ■ apply as needed

Additionally when using for Diaper Rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

lanolin, vitamin A palmitate, vitamin D3 in corn oil, quaternium-15

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049072petrolatum 76 % Topical OintmentPSN7
1049072petrolatum 0.76 MG/MG Topical OintmentSCD7
1049072petrolatum 76 % Topical OintmentSY7

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
52410-8036-22023-07-28C16284748780-10191ceaa-712f-198a-e063-dbdaa90aec3eDrug Facts
52410-8036-32023-07-28C16284748780-10191ceaa-712f-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-8036-2AmeriDermVitamin A D100 g in 1 TUBEOINTMENT1007
52410-8036-3AmeriDermVitamin A D425 g in 1 JAROINTMENT4257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-8036AMERIDERM VITAMIN A D (WHITE PETROLATUM) OINTMENT [SHIELD LINE LLC]7Legacy NDC, 2 package rows20220114_f39554f6-f147-4b53-bbb2-c50b2d21fe83.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF412
CORN OILINACTIVE INGREDIENT8470G57WFM2
LANOLININACTIVE INGREDIENT7EV65EAW6H2
QUATERNIUM-15INACTIVE INGREDIENTE40U03LEM02
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52410-803652410-8036-2, 52410-8036-3

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
VITAMIN A PALMITATE1D1K0N0VVCIACT
CHOLECALCIFEROL1C6V77QF41IACT
CORN OIL8470G57WFMIACT
QUATERNIUM-15E40U03LEM0IACT
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 · 23 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CORN OILCORN OIL8470G57WFMTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, COATED / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION / ORAL2.5 ml/5mlExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0LOTION / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM, AUGMENTED / TOPICAL0.1 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCAPSULE / ORAL918 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / ORAL20 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / SUBLINGUAL1.7 mgExact identifier — unii candidate
11 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
d57aa512-327f-7fab-e053-2a95a90aa4e6f39554f6-f147-4b53-bbb2-c50b2d21fe832022-01-13WarningsExact identifier
spl id: d57aa512-327f-7fab-e053-2a95a90aa4e6
spl set id: f39554f6-f147-4b53-bbb2-c50b2d21fe83

Reported adverse events (FAERS/openFDA)#

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