GRANDMA ELS- diaper rash ointment ointment 
ABBE Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Purpose
.......Protectant, Emollient
.......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 • symtoms last more than 7 day or clear up and occur again within a few days

Do not use on • deep or puncture wounds • animal 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. Cleanse 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, Benzly Cinnamate (extracts of balsam of peru)

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

Mfd. by ABBE Laboratories, Inc. Farmingdale, NY

www.GrandmaEls.com

———PACKAGE LABEL.PRINCIPAL DISPLY 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

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
GRANDMA ELS 
diaper rash ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68605-2007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.7595 g  in 1 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN0.155 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
BENZYL CINNAMATE (UNII: V67O3RO97U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68605-2007-356.7 g in 1 TUBE; Type 0: Not a Combination Product02/01/2015
2NDC:68605-2007-4106.3 g in 1 JAR; Type 0: Not a Combination Product02/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2015
Labeler - ABBE Laboratories, Inc. (781745286)
Establishment
NameAddressID/FEIBusiness Operations
ABBE Laboratories, Inc.781745286manufacture(68605-2007)

Revised: 1/2022
Document Id: 5db7d7f5-8fe7-4aa8-8c3d-65649f27cabc
Set id: b331c46d-855f-45f5-b3ee-3a611370face
Version: 5
Effective Time: 20220114
 
ABBE Laboratories, Inc.