FDA.reportPublic FDA data

Endit zinc oxide skin protection

Manufacturer
EndIt Laboratories, Inc.
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:51:48

Label at a glance#

ProductEndit zinc oxide skin protection
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urin, Protects chafed skin due to diaper rash and helps seal out wetness.

Dosage and administration

For treatment of diaper rash: Change wet and soiled diapers promptly. Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry.  Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled diapers (feces, and/or urine) 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 rash associated with diaper use, incontinence, or exposure to feces and urin, 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 in eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens.
  • Symptoms last more than 7 days or clear up and occur again within a few days.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

For treatment of diaper rash:

  • Change wet and soiled diapers promptly.
  • Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry. 
  • Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled diapers (feces, and/or urine) may be prolonged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol, White Petrolatum

Package Labeling:56.7 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:113.4 g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:227g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN3
198911zinc oxide 0.2 MG/MG Topical OintmentSCD3
198911zinc oxide 20 % Topical OintmentSY3
198911zinc oxide 200 MG per GM Topical OintmentSY3
198911ZNO 0.2 MG/MG Topical OintmentSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130364068000021GTIN-13: 0364068000021
EAN-13: 0364068000021
GTIN-12: 364068000021
UPC-A: 364068000021
GTIN storage (14 digits): 00364068000021		Label.jpg
BarcodeEAN-130364068000045GTIN-13: 0364068000045
EAN-13: 0364068000045
GTIN-12: 364068000045
UPC-A: 364068000045
GTIN storage (14 digits): 00364068000045		Label2.jpg
BarcodeEAN-130364068000083GTIN-13: 0364068000083
EAN-13: 0364068000083
GTIN-12: 364068000083
UPC-A: 364068000083
GTIN storage (14 digits): 00364068000083		Label3.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64068-500-01Endit zinc oxide skin protection56.7 g in 1 JAROINTMENT56.73
64068-500-02Endit zinc oxide skin protection113.4 g in 1 JAROINTMENT113.43
64068-500-03Endit zinc oxide skin protection227 g in 1 JAROINTMENT2273

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
64068-50064068-500-01, 64068-500-02, 64068-500-03

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
BORIC ACIDR57ZHV85D4IACT
STARCH, CORNO8232NY3SJIACT
JUNIPER TAR1Q84T0P2G3IACT
LANOLIN7EV65EAW6HIACT
RESORCINOLYUL4LO94HKIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22023-12-15full-release2026-06-01 00:04:31

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
Endit zinc oxide skin protectionZINC OXIDEEndIt Laboratories, Inc.e60bb0da-3349-f8f9-e053-2a95a90a90512026-01-09WarningsExact identifier
ndc (package): 64068-500-03
ndc (package): 64068-500-02
ndc (package): 64068-500-01
ndc (product): 64068-500
ndc11 (package): 64068050002
ndc11 (package): 64068050001
ndc11 (package): 64068050003
spl id: 47f5517a-46c6-6d06-e063-6394a90aa5c9
spl set id: e60bb0da-3349-f8f9-e053-2a95a90a9051

Reported adverse events (FAERS/openFDA)#

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