Delsam Pharma's Diaperene™ Children 13% Zinc Oxide Diaper Rash Cream

Manufacturer
Delsam Pharma Llc
Effective date
2021-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:03

Label at a glance#

ProductDIAPERENE CHILDREN
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

• 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

Storage and handling

• Store at 20° to 25° C (68° to 77° F). • Protect from freezing • May stain clothing

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (13%)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

• Helps treat and prevent diaper rash

• Protect chafed skin due to diaper rash and helps seal out wetness

Warnings:

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

• 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:

STORAGE AND HANDLING SECTION

• Store at 20° to 25° C (68° to 77° F).

• Protect from freezing

• May stain clothing

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

QUESTIONS OR COMMENTS:

OTC - QUESTIONS SECTION

1-866-826-1306 between 11am to 4 pm EST, Monday-Friday (or) mail to delsampharma@yahoo.com

SPL UNCLASSIFIED SECTION

*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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72570-12372570-123-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
640d1388-9f43-4294-85b8-a97b251b7d4901af1c8a-19b0-4002-99fe-6dedffc8073a2023-03-15WarningsExact identifier
spl set id: 01af1c8a-19b0-4002-99fe-6dedffc8073a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.