DIAPERENE CHILDREN- zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Delsam Pharma Llc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant • Helps treat and prevent diaper rash  • Protect chafed skin due to diaper rash and helps seal out wetness

Authorization status:

OTC monograph final

Summary of Product characteristics

DIAPERENE CHILDREN- ZINC OXIDE CREAM
DELSAM PHARMA LLC
_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._
----------
_DELSAM PHARMA'S DIAPERENE™ CHILDREN_
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Zinc Oxide (13%)
_PURPOSE_
Skin Protectant
USES:
• Helps treat and prevent diaper rash
• Protect chafed skin due to diaper rash and helps 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 for more than 7 days or clear up and occur again
within a few days.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away.
_DIRECTIONS:_
• Change wet or soiled diapers promptly
• Cleanse the diaper area
• Allow to dry
• Apply cream liberally as often as necessary, with each diaper
change, especially at
bedtime or any time when exposure to wet diapers may be prolonged
OTHER INFORMATION:
• Store at 20° to 25°C (68° to 77°F)
• Protect from freezing
• May stain clothing
INACTIVE INGREDIENTS:
Light Liquid Paraffin, White Petroleum Jelly, Hard Paraffin Wax,
Microcrystalline Wax,
Glycerin, Cetostearyl Alcohol, Cetyl Alcohol, Bees Wax, Sorbitol,
Phenoxyethanol, Shea
Butter, Dimethicone-3031, Magnesium Sulphate & Potassium Hydroxide.
QUESTIONS OR COMMENTS:
1-866-826-1306 between 11am to 4 pm EST, Monday-Friday (or) mail to
[e-mail]
*COMPARE TO THE ACTIVE INGREDIENT IN DESITIN DAILY DEFENCE
_PROTECTS AGAINST DIAPER RASH FROM THE FIRST USE_
DIAPER RASH CREAM
FREE FROM PARABENS,
PHTHALATES,
DYES AND FRAGRANCE
HYPOALLERGENIC.
PEDIATRICIAN & DERMATOLOGIST TESTED
Works at the first hint of rash
Easy to apply, easy to remove
Gentle enough to use everyday
Distributed by:
DELSAM PHARMA LLC
MAMARONECK NY 10543
PACKAGING
®
DIAPERENE CHILDREN
zinc oxide cream
PRODUCT IN