GRANDMA ELS- diaper rash ointment ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)

Available from:

ABBE Laboratories, Inc.

INN (International Name):

PETROLATUM

Composition:

PETROLATUM 0.7595 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 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

Authorization status:

OTC monograph final

Summary of Product characteristics

GRANDMA ELS- DIAPER RASH OINTMENT OINTMENT
ABBE LABORATORIES, INC.
_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._
----------
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
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)
OTHER INGREDIENTS:
Tocopherol Acetate (Vitamin E), Cetyl Esters, Ethyl
Methylphenylglycidate, Benzly
Cinnamate (extracts of balsam of peru)
For Questions call [phone] Mon-Fri
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 ba