FDA.reportPublic FDA data

MEDPURA Zinc Oxide 20% Ointment Regular Strength

Manufacturer
Akron Pharma Inc.
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:33:05

Label at a glance#

ProductMedpura Zinc Oxide 20%
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness protects and dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

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 and 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 20%

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
  • protects and dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

Warnings

WARNINGS SECTION

For External Use Only

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 and especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature 20˚-25˚C (68˚-77˚F)
  • may stain clothing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alovera gel, mineral oil, white petrolatum

Questions and Comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-225-6999

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122334455

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN5
198911zinc oxide 0.2 MG/MG Topical OintmentSCD5
198911zinc oxide 20 % Topical OintmentSY5
198911zinc oxide 200 MG per GM Topical OintmentSY5
198911ZNO 0.2 MG/MG Topical OintmentSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371399024527GTIN-13: 0371399024527
EAN-13: 0371399024527
GTIN-12: 371399024527
UPC-A: 371399024527
GTIN storage (14 digits): 00371399024527		2OZ LABEL.jpg
BarcodeEAN-130371399024534GTIN-13: 0371399024534
EAN-13: 0371399024534
GTIN-12: 371399024534
UPC-A: 371399024534
GTIN storage (14 digits): 00371399024534		3OZ LABEL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0245-2Medpura Zinc Oxide 20%1 in 1 CARTONOINTMENT15
71399-0245-2Medpura Zinc Oxide 20%56.7 g in 1 TUBEOINTMENT56.75
71399-0245-3Medpura Zinc Oxide 20%85 g in 1 TUBEOINTMENT855
71399-0245-3Medpura Zinc Oxide 20%1 in 1 CARTONOINTMENT15
71399-0245-6Medpura Zinc Oxide 20%454 g in 1 JAROINTMENT4545

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0245-2GM - Gram71399-02452ea9c133-b71e-45b1-9261-eb5c2aab6d9012022-12-07
71399-0245-3GM - Gram71399-0245cd20344b-dd97-4472-b7d9-4919a09bcb8f12022-01-06
71399-0245-6GM - Gram71399-0245c7b7b919-77a4-4ce4-b13e-6bc3edc8e0ba12021-12-08

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-024571399-0245-2, 71399-0245-3, 71399-0245-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
MINERAL OILT5L8T28FGPIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
ZINC OXIDESOI2LOH54ZACTIB

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
Medpura Zinc Oxide 20%MEDPURA ZINC OXIDE 20%Akron Pharma Inc.3a63aaea-087e-4115-8478-64d416e6085f2026-01-14WarningsExact identifier
ndc (package): 71399-0245-3
ndc (package): 71399-0245-6
ndc (package): 71399-0245-2
ndc (product): 71399-0245
ndc11 (package): 71399024503
ndc11 (package): 71399024506
ndc11 (package): 71399024502
spl id: 4861cc3a-ca26-82e8-e063-6294a90a1bff
spl set id: 3a63aaea-087e-4115-8478-64d416e6085f

Reported adverse events (FAERS/openFDA)#

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