- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
———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 ointmentProduct 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)