FDA.reportPublic FDA data

Grandma Els

Manufacturer
ABBE Laboratories, Inc.
Effective date
2026-01-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:52:38

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

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)

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) 457-0990 Mon-Fri

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Warnings continued: Do not use on: • deep or puncture

wounds • animals bites • serious burns

Keep out of reach of children.  If swallowed, get

medical help or contact a Poison Control Center

Directions: Change wet and soiled diapers promptly.

Cleans diaper area and allow to dry.  Apply a thin film of

ointment to entire diaper area with every diaper change.

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

Other Ingredients: 

Tocopherol Acetate (Vitamin E), Cetyl Esters,

Ethyl Methylphenylglycidate, Benzyl Cinnamate

(extracts of balsam of peru)

For Questions call (800) 457-0990 Mon-Fri

Mfd. by ABBE Laboratories, Inc. Farmingdale, NY

wwwGrandmaEls.com

Creates a

Breathable Barrier

Use with Every

Diaper Change

Soothes, Calms

+ Heals

NET WT 3.75 OZ.

GRANDMA EL'S

Diaper Rash Ointment

Made in the USA

Pediatrician Recommended

DOES NOT CONTAIN

PARABENS,

PHTHALATES OR SLS

DRUG FACTS:

Active Ingredients                        Purpose

Amber Petrolatum 75.95%..........Protectant, Emollient

Lanolin USP 15.50%...................Protectant, Emollient

Uses: Helps treat and prevent diaper rash

  • Protects and heals chafed and irritated skin
  • Provides barrier to seal out wetness

Warnings:

For external use only

When using this product • do not get into eyes

Stop use and ask a doctor if • condition worsens

• symptoms last more than 7 days or clear up and

occur again within a few days

2001-16

3 52248 00001 5

Product Label
Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1649558lanolin 15.5 % / petrolatum 75.95 % Topical OintmentPSN7
1649558lanolin 0.155 MG/MG / petrolatum 0.8 MG/MG Topical OintmentSCD7
1649558lanolin 15.5 % / petrolatum 75.95 % Topical OintmentSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130352248000015GTIN-13: 0352248000015
EAN-13: 0352248000015
GTIN-12: 352248000015
UPC-A: 352248000015
GTIN storage (14 digits): 00352248000015		product-label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68605-2007-3Grandma Els56.7 g in 1 TUBEOINTMENT56.77
68605-2007-4Grandma Els106.3 g in 1 JAROINTMENT106.37

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
68605-200768605-2007-3, 68605-2007-4

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-10-16full-release2026-06-01 00:26:24

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
Grandma ElsDIAPER RASH OINTMENTABBE Laboratories, Inc.b331c46d-855f-45f5-b3ee-3a611370face2026-01-10WarningsExact identifier
ndc (package): 68605-2007-4
ndc (package): 68605-2007-3
ndc (product): 68605-2007
ndc11 (package): 68605200704
ndc11 (package): 68605200703
spl id: 7a36640e-a45f-47af-9df8-1411df06ff97
spl set id: b331c46d-855f-45f5-b3ee-3a611370face

Reported adverse events (FAERS/openFDA)#

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