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 MEADOWBROOK LABS, INC., ABBE Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:                                       NDC #52248-200-41

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 Helps alleviate pain, itching and redness associated with diaper rash

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)
                                 May stain clothing

INACTIVE INGREDIENT

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

QUESTIONS

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———

GRANDMA EL'S

Diaper Rash
Ointment

Pediatrician
Recommended

Prevent Protect Treat

Made in the USA
NET WT. 2 OZ

INGREDIENTS AND APPEARANCE

GRANDMA ELS 
diaper rash ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52248-200
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: 52248-200-41	56.7 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 52248-200-42	106.3 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 52248-200-43	1.75 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - MEADOWBROOK LABS, INC. (799274183)

Establishment
Name	Address	ID/FEI	Business Operations
ABBE Laboratories, Inc.		781745286	manufacture(52248-200)