Delsam Pharma's Diaperene™ Maximum 40% Zinc Oxide Diaper Rash Cream

Manufacturer
Delsam Pharma Llc
Effective date
2021-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:06

Label at a glance#

ProductDIAPERENE MAXIMUM
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

• Change wet and 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 anytime when exposure to wet diapers may be prolonged

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 40%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

• Helps treat and prevent diaper rash

• Protects 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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Change wet and 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 anytime when exposure to wet diapers may be prolonged

Other Information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

White soft paraffin, Glycerine, Purified talc, Light liquid paraffin, 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®Maximun Strength

Protects against diaper rash from the first use

Free from Parabens, Phthalates, Dyes and Fragrance Hypoallergenic. Pediatrician & Dermatologist tested

| Provides overnight protection | Instantly forms a protective barrier | Healing you can see, relief your baby can feel |

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
72570-12472570-124-16

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#

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d2a4261a-d34c-47c3-be9e-b1c7ac386af14d4d7e8f-189d-4a46-8065-db13c1924a402023-03-15WarningsExact identifier
spl set id: 4d4d7e8f-189d-4a46-8065-db13c1924a40

Reported adverse events (FAERS/openFDA)#

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