FDA.reportPublic FDA data

Diaprex Ointment

Manufacturer
Elba, Inc.
Effective date
2021-05-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:45:07

Label at a glance#

ProductDiaprex
Active ingredientZINC OXIDE, PETROLATUM
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash and other minor skin irritations. Protects chafed skin and helps seal out wetness

Dosage and administration

Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply ointment liberally as often as necessary with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 67.6% .................................................
Zinc Oxide 9.6%..............................................................

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash and other minor skin irritations.
  • Protects chafed skin and helps seal out wetness

Warnings

WARNINGS SECTION

  • For External Use Only

When using this product

OTC - WHEN USING SECTION

do not get into eyes.

OTC - ASK DOCTOR SECTION

If irritation occurs or if there is no improvement within 7 days discontinue use and consult a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply ointment liberally as often as necessary with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature (59–86°F) (15-30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Magnesium Stearate, White Beeswax, Castor Oil, and Balsam Peru.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DiaprexLabelDiaprexLabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10031-01510031-015-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
MAGNESIUM STEARATE70097M6I30IACT
WHITE WAX7G1J5DA97FIACT
CASTOR OILD5340Y2I9GIACT
BALSAM PERU8P5F881OCYIACT
ZINC OXIDESOI2LOH54ZACTIM
PETROLATUM4T6H12BN9UACTIB

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
c1fd8a05-8ea4-e3aa-e053-2a95a90a0878af67f560-8cb7-4ab7-9195-73e46d17978c2021-05-10WarningsExact identifier
spl id: c1fd8a05-8ea4-e3aa-e053-2a95a90a0878
spl set id: af67f560-8cb7-4ab7-9195-73e46d17978c

Reported adverse events (FAERS/openFDA)#

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