FDA.reportPublic FDA data

Diaprex

Manufacturer
Elba, Inc.
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:56:50

Label at a glance#

ProductDiaprex
Active ingredientZINC OXIDE
Label structure7 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 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 betime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.6%

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

OTC - WHEN USING SECTION

do not get into eyes.

Stop use and ask doctor

OTC - STOP USE SECTION

if condition worsens or symptoms last more than 7 days or clear up and occur again in a few days.

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 betime 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

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelTubeTube

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10031-00610031-006-04, 10031-006-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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

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
c1fd814a-a600-e3fd-e053-2a95a90aee6a48966ca3-2664-5a02-e054-00144ff88e882021-05-10WarningsExact identifier
spl set id: 48966ca3-2664-5a02-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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