GRANDMA ELS- diaper rash ointment ointment

Grandma Els by

Drug Labeling and Warnings

Grandma Els by is a Otc medication manufactured, distributed, or labeled by ABBE Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT

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

PURPOSE

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

INDICATIONS & USAGE

Uses: Helps treat and prevent diaper rash Protects and heals chafed and irritated skin Provides barrier to seal out wetness

WARNINGS

Warnings:
For external use only

WHEN USING

When using this product do not get into eyes

STOP USE

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

Do not use on deep or puncture wounds animal bites serious burns

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

DOSAGE & ADMINISTRATION

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

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

QUESTIONS

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

SPL UNCLASSIFIED SECTION

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

• 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

INGREDIENTS AND APPEARANCE

GRANDMA ELS 
diaper rash ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68605-2007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	0.7595 g  in 1 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	0.155 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)
BENZYL CINNAMATE (UNII: V67O3RO97U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68605-2007-3	56.7 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2015
2	NDC: 68605-2007-4	106.3 g in 1 JAR; Type 0: Not a Combination Product	02/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/01/2015

Labeler - ABBE Laboratories, Inc. (781745286)

Establishment
Name	Address	ID/FEI	Business Operations
ABBE Laboratories, Inc.		781745286	manufacture(68605-2007)