Diaperene Children

Manufacturer
Delsam Pharma Llc
Effective date
2021-09-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:36:47

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

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:

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DiapC -1DiapC -1DiapC -2DiapC -2

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72570-13272570-132-16, 72570-132-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bed4fa1b-913a-4730-99ad-fc39bd3797243328883e-8443-4f76-bf5d-295259d9116c2021-09-27WarningsExact identifier
spl set id: 3328883e-8443-4f76-bf5d-295259d9116c

Reported adverse events (FAERS/openFDA)#

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