FDA.reportPublic FDA data

MedPak Derma Guard Ointment

Manufacturer
Elba, Inc.
Effective date
2017-08-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:14:03

Label at a glance#

ProductMedPak Derma Guard
Active ingredientZINC OXIDE
Label structure7 sections

Dosage and administration

Change wet or soiled diapers promtly. 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 Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.6%

Purpose

OTC - PURPOSE SECTION

Skin Protectant 

Use:

INDICATIONS & USAGE SECTION

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

Warning:

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 promtly. 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

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10031-011-002021-01-26C16284748780-19d75b9d0-5f7a-f424-e053-dadaa90a57ceMedPak Derma Guard Ointment
10031-011-002020-01-31C16284748780-19d75b9d0-5f7a-f424-e053-dadaa90a57ceMedPak Derma Guard Ointment

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
10031-01110031-011-00

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
9996ec2d-28dc-7d91-e053-2a95a90a89f08602db7e-5058-408b-aa01-31958608199f2021-01-26WarningsExact identifier
spl set id: 8602db7e-5058-408b-aa01-31958608199f

Reported adverse events (FAERS/openFDA)#

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