Label: GRANDMA ELS- diaper rash ointment ointment
- NDC Code(s): 68605-2007-3, 68605-2007-4
- Packager: ABBE Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated January 14, 2022
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- Official Label (Printer Friendly)
- 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
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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)