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Grandma Els by MEADOWBROOK LABS, INC.

Medically reviewed on December 1, 2017

Dosage form: ointment
Ingredients: PETROLATUM 0.7595g in 1g, LANOLIN 0.155g in 1g
Labeler: MEADOWBROOK LABS, INC.
NDC Code: 52248-200

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.

DRUG FACTS:                                       NDC #52248-200-41

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 • Helps alleviate pain, itching and redness associated with 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 • 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)
                                 May stain clothing

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

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

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

GRANDMA ELS 
diaper rash ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52248-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM0.7595 g  in 1 g
LANOLIN (LANOLIN) LANOLIN0.155 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE 
CETYL ESTERS WAX 
ETHYL METHYLPHENYLGLYCIDATE 
BENZYL CINNAMATE 
Packaging
#Item CodePackage Description
1NDC:52248-200-4156.7 g in 1 TUBE
2NDC:52248-200-42106.3 g in 1 JAR
3NDC:52248-200-431.75 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2015
Labeler - MEADOWBROOK LABS, INC. (799274183)
Establishment
NameAddressID/FEIOperations
ABBE Laboratories, Inc.781745286manufacture(52248-200)

 
MEADOWBROOK LABS, INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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