Diaperene Maximum

Manufacturer
Delsam Pharma Llc
Effective date
2021-09-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:36:47

Label at a glance#

ProductDiaperene Maximum
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 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

• 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 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

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® Maximum Strength

Protects against diaper rash from the first use

Diaper Rash Cream

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

Maxim1Maxim1Maxim2Maxim2Maxim3Maxim3

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72570-13372570-133-16, 72570-133-09

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
8aa91a30-82af-49a8-a8c7-23e9a36e258302afd3f4-bbc7-4f13-8454-40bfd9d4c9dd2021-09-27WarningsExact identifier
spl set id: 02afd3f4-bbc7-4f13-8454-40bfd9d4c9dd

Reported adverse events (FAERS/openFDA)#

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