FDA.reportPublic FDA data

Endit Zinc Oxide Skin Protectant

Manufacturer
Endit Laboratories, Inc. | Filltech USA, LLC
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:51:37

Label at a glance#

ProductEndit Zinc Oxide Skin Protectant
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

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 dapers (feces, and/or urine) may be prolonged.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.00%

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 urine. Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings:

WARNINGS SECTION

For external use only.

do not get in eyes. When using this product

Stop use and ask doctor if

Condition worsens.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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 dapers (feces, and/or urine) may be prolonged.

Other Ingredients:

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198911zinc oxide 20 % Topical OintmentPSN7
198911zinc oxide 0.2 MG/MG Topical OintmentSCD7
198911zinc oxide 20 % Topical OintmentSY7
198911zinc oxide 200 MG per GM Topical OintmentSY7
198911ZNO 0.2 MG/MG Topical OintmentSY7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64068-402-012020-02-24C16284748780-19d75b9d0-2935-f424-e053-dadaa90a57ceEndit! Zinc Oxide Skin Protectant
64068-402-012020-02-24C16284748780-19d75b9d0-2935-f424-e053-dadaa90a57ceEndit! Zinc Oxide Skin Protectant
64068-402-012020-01-31C16284748780-19d75b9d0-2935-f424-e053-dadaa90a57ceEndit! Zinc Oxide Skin Protectant
64068-402-012020-01-31C16284748780-19d75b9d0-2935-f424-e053-dadaa90a57ceEndit! Zinc Oxide Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64068-402-01Endit Zinc Oxide Skin Protectant454 g in 1 JAROINTMENT4547

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64068-40264068-402-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
FERRIC OXIDE RED1K09F3G675IACT
STARCH, CORNO8232NY3SJIACT
JUNIPER TAR1Q84T0P2G3IACT
LANOLIN7EV65EAW6HIACT
RESORCINOLYUL4LO94HKIACT
PETROLATUM4T6H12BN9UIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62023-12-15full-release2026-06-01 00:04:21

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 ProtectantZINC OXIDEEndit Laboratories, Inc.55b3aa07-871d-421b-b76a-c2d359d6003f2026-01-09WarningsExact identifier
ndc (package): 64068-402-01
ndc (product): 64068-402
ndc11 (package): 64068040201
spl id: 47f5536e-340b-7f85-e063-6394a90ad4a4
spl set id: 55b3aa07-871d-421b-b76a-c2d359d6003f

Reported adverse events (FAERS/openFDA)#

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