FDA.reportPublic FDA data

Grandma Els

Manufacturer
MEADOWBROOK LABS, INC. | ABBE Laboratories, Inc.
Effective date
2014-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:32:02

Label at a glance#

ProductGrandma Els
Active ingredientPETROLATUM, LANOLIN
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
Amber Petroluatum 75.95%...........
Lanolin 15.50%..............................

OTC - PURPOSE SECTION

Purpose
.......Protectant, Emollient
.......Protectant, Emollient

INDICATIONS & USAGE SECTION

Uses: Helps treat and prevent diaper rash • Protects and heals chafed and irritated skin • Provides barrier to seal out wetness • Helps alleviate pain, itching and redness associated with diaper rash

WARNINGS SECTION

Warnings:
For external use only

OTC - WHEN USING SECTION

When using this product • do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if • condition worsens • symtoms last more than 7 day or clear up and occur again within a few days

OTC - DO NOT USE SECTION

Do not use on • deep or 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

DOSAGE & ADMINISTRATION SECTION

Directions: Change wet and soiled diapers promptly. Cleanse diaper area and allow to dry. Apply a thin film of ointment to entire diaper area with every diaper change.

OTHER SAFETY INFORMATION

Other Information: Store at 20° to 25°C (68° to 77°F)
                                 May stain clothing

INACTIVE INGREDIENT SECTION

Other Ingredients:
Tocopherol Acetate (Vitamin E), Cetyl Esters, Ethyl Methylphenylglycidate, Benzly Cinnamate (extracts of balsam of peru)

OTC - QUESTIONS SECTION

For Questions call (800) 493-0223 Mon-Fri

SPL UNCLASSIFIED SECTION

Works with most cloth diapers
please contact your diaper manufacturer
Mfd for Meadowbrook Labs, Inc., Farmingdale, NY

DOES NOT CONTAIN PARABENS, PHTHALATES, OR SLS.

www.GrandmaEls.com

———PACKAGE LABEL.PRINCIPAL DISPLY PANEL———

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GRANDMA EL'S

Diaper Rash
Ointment

Pediatrician
Recommended

Prevent • Protect • Treat

Made in the USA
NET WT. 2 OZ

Product Label
Product Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52248-200-412025-11-26C16284748780-19d75b9d0-4573-f424-e053-dadaa90a57ce7dc80455-a326-478c-8b3a-1f38f31fd97c
52248-200-422025-11-26C16284748780-19d75b9d0-4573-f424-e053-dadaa90a57ce7dc80455-a326-478c-8b3a-1f38f31fd97c
52248-200-432025-11-26C16284748780-19d75b9d0-4573-f424-e053-dadaa90a57ce7dc80455-a326-478c-8b3a-1f38f31fd97c
52248-200-412020-01-31C16284748780-19d75b9d0-4573-f424-e053-dadaa90a57ce7dc80455-a326-478c-8b3a-1f38f31fd97c
52248-200-422020-01-31C16284748780-19d75b9d0-4573-f424-e053-dadaa90a57ce7dc80455-a326-478c-8b3a-1f38f31fd97c
52248-200-432020-01-31C16284748780-19d75b9d0-4573-f424-e053-dadaa90a57ce7dc80455-a326-478c-8b3a-1f38f31fd97c

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52248-200GRANDMA ELS (DIAPER RASH OINTMENT) OINTMENT [MEADOWBROOK LABS, INC.]1Legacy NDC20150513_7dc80455-a326-478c-8b3a-1f38f31fd97c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LANOLINACTIVE INGREDIENT7EV65EAW6H1
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
LANOLINACTIVE MOIETY7EV65EAW6H1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
BENZYL CINNAMATEINACTIVE INGREDIENTV67O3RO97U1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GU1
ETHYL METHYLPHENYLGLYCIDATEINACTIVE INGREDIENTUD51D5KR4A1

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
52248-20052248-200-41, 52248-200-42, 52248-200-43

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
PETROLATUM4T6H12BN9UACTIB
LANOLIN7EV65EAW6HACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETYL ESTERS WAXD072FFP9GUIACT
ETHYL METHYLPHENYLGLYCIDATEUD51D5KR4AIACT
BENZYL CINNAMATEV67O3RO97UIACT

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 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GULOTION / TOPICAL1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUCREAM / TOPICAL10.3 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUSUPPOSITORY / VAGINALNAExact identifier — unii candidate
5 equally ranked IID candidates
CETYL ESTERS WAXCETYL ESTERS WAXD072FFP9GUCREAM / VAGINAL3 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 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
87e05f97-3d38-4d9c-b6cd-923725359c0d7dc80455-a326-478c-8b3a-1f38f31fd97c2025-11-26WarningsExact identifier
spl set id: 7dc80455-a326-478c-8b3a-1f38f31fd97c

Reported adverse events (FAERS/openFDA)#

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