Diaperene Adult

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 22:36:49

Label at a glance#

ProductDiaperene Adult
Active ingredientMENTHOL, UNSPECIFIED FORM, ZINC OXIDE
Label structure10 sections

Indications and uses

• Protects and Helps Heal Skin Irritations From • Incontinence of Urine or Diarrhea • Feeding Tube Site Leakage • Diaper Rash • Wound Drainage • Minor Cuts & Scrapes • Bedsores • Burns/ Irradiated Skin • Temporarily Relieves Discomfort & Itching

Dosage and administration

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Diaperene Adult Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Storage and handling

• Store between: 15-30°C (59-86°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44%

Zinc Oxide 20.6%.

PURPOSE

OTC - PURPOSE SECTION

External Analgesic / Anti-itch

Skin Protectant, Anorectal Astringent

Uses

INDICATIONS & USAGE SECTION

• Protects and Helps Heal Skin Irritations From • Incontinence of Urine or Diarrhea • Feeding Tube Site Leakage • Diaper Rash • Wound Drainage • Minor Cuts & Scrapes • Bedsores • Burns/ Irradiated Skin • Temporarily Relieves Discomfort & Itching

Warnings

WARNINGS SECTION

For external use only. Not for deep or puncture wounds. Avoid contact with eyes. In case of accidental ingestion contact a physician or poison control center immediately. If condition worsens or does not improve within 7 days, consult a doctor.

When using this product

• Certain persons can develop allergic reactions to ingredients in this product.  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.  • Do not exceed the recommended daily dosage unless directed by a doctor.

Stop use and ask a doctor if

• Bleeding occurs  • Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Diaperene Adult Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Other information

STORAGE AND HANDLING SECTION

• Store between: 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Light Liquid Paraffin, White Petroleum Jelly, Hard Paraffin Wax, Microcrystalline Wax, Calamine, Lanolin, Glycerin, Cetostearyl alcohol, Cetyl Alcohol & Thymol.

Questions or Comments

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

* Compare to the active ingredient in Calmoseptine® Ointment

A Multipurpose Moisture Barrier Ointment

LONG - LASTING PROTECTION

Temporarily protects irritated areas

Temporary relief of pain or burning and skin irritations

Distributed by:

DELSAM PHARMA LLC

MAMARONECK NY 10543

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DiaAd1DiaAd1DiaAd2DiaAd2

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72570-13472570-134-16, 72570-134-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
876514f9-92b6-4138-86b6-34cb91e2ccd761bbd3e0-3895-4b4c-9e5e-db41f3a8bf502021-09-27WarningsExact identifier
spl set id: 61bbd3e0-3895-4b4c-9e5e-db41f3a8bf50

Reported adverse events (FAERS/openFDA)#

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