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 13% Zinc Oxide Diaper Rash Cream

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:

White soft paraffin, Light liquid paraffin, Sorbitan monostearate, Glycerin, Purified water

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

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

image description

DIAPERENE CHILDREN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72570-123
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72570-123-16	454 g in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2021	03/15/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/01/2021	03/15/2023

Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023

Document Id: 640d1388-9f43-4294-85b8-a97b251b7d49

Set id: 01af1c8a-19b0-4002-99fe-6dedffc8073a

Version: 2

Effective Time: 20230315

Delsam Pharma Llc