Diaperene™ Children Maximum

Diaperene Children Maximum by

Drug Labeling and Warnings

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

Drug Details [pdf]

DIAPERENE CHILDREN MAXIMUM- 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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Diaperene™ Children Maximum

Drug Facts

ACTIVE INGREDIENTS

Zinc Oxide (40%)

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

Protects against diaper rash from the first use

40% Zinc Oxide 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 MAXIMUM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-137-03	1 in 1 CARTON	08/23/2022	03/15/2023
1		90 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	08/23/2022	03/15/2023

Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023

Document Id: 55f836c6-88a7-477e-9351-97c4ffba1f2d

34390-5

Set id: cdb4926a-4ce8-4be2-ab5a-1b3af45f53db

Version: 2

Effective Time: 20230315