Otc - Active Ingredient
Active Ingredients
Amber Petroluatum 75.95%...........
Lanolin 15.50%..............................
Grandma Els Ointment
FDA Label NDC 68605-2007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Abbe Laboratories, Inc. for the product Grandma Els (NDC 68605-2007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - When Using
When using this product • do not get into eyes
Otc - 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
Otc - Do Not Use
Do not use on • deep or puncture wounds • animal bites • serious burns
Otc - 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)
Otc - Questions
For Questions call (800) 457-0990 Mon-Fri
Other
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
Product Label (Product Label)
* Please review the disclaimer below.
