Delsam Pharma's  Diaperene™ Children

Diaperene Children by

Drug Labeling and Warnings

Diaperene Children by is a Otc medication manufactured, distributed, or labeled by Delsam Pharma Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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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 delsampharma@yahoo.com

*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 Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	130 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
YELLOW WAX (UNII: 2ZA36H0S2V)
SORBITOL (UNII: 506T60A25R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-132-16	454 g in 1 CONTAINER; Type 0: Not a Combination Product	07/01/2021	09/27/2021
2	NDC: 72570-132-09	1 in 1 CARTON	09/06/2021	09/27/2021
2		256 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2021	09/27/2021

Labeler - Delsam Pharma Llc (081369679)

Revised: 9/2021

Document Id: bed4fa1b-913a-4730-99ad-fc39bd379724

34390-5

Set id: 3328883e-8443-4f76-bf5d-295259d9116c

Version: 3

Effective Time: 20210927