FDA.reportPublic FDA data

Zinc Oxide Cream

Manufacturer
Emerging Pharma, LLC
Effective date
2022-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:25

Label at a glance#

ProductZinc Oxide Cream
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

• helps treat and prevent diaper rash • protects chafed skin due to diaper rash and helps protect skin from wetness.

Dosage and administration

Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream 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 22%

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 protect skin from wetness.

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

• conditions worsen
• 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, and allow to dry.
  • Apply cream 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 20-30°C (68-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E), white petrolatum

Questions ? 

OTC - QUESTIONS SECTION

Call 1-844-221-7294.

SPL UNCLASSIFIED SECTION

Manufactured for 

Emerging Pharmaceuticals
New Jersey, USA

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70050-100-04 NET WT: 4 oz (113 grams)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1734937zinc oxide 22 % Topical CreamPSN1
1734937zinc oxide 220 MG/ML Topical CreamSCD1
1734937zinc oxide 22 % Topical CreamSY1
1734937ZNO 220 MG/ML Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70050-100-042024-01-30C16284748780-11030e365-53c6-111a-e063-dadaa90a10e2Zinc Oxide Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70050-100-04Zinc Oxide Cream113 g in 1 JARCREAM1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70050-100ZINC OXIDE CREAM (ZINC OXIDE) CREAM [EMERGING PHARMA, LLC]1Legacy NDC, 1 package rows20220503_70f85a4a-d4d6-4863-bdb3-2ef8d85986e7.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70050-10070050-100-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETYL ALCOHOL936JST6JCNIACT
CHLORPHENESINI670DAL4SZIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WHITE PETROLATUMB6E5W8RQJ4IACT

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
854c3e8a-b7db-4a06-9196-19390fd9ff7370f85a4a-d4d6-4863-bdb3-2ef8d85986e72022-05-01WarningsExact identifier
spl id: 854c3e8a-b7db-4a06-9196-19390fd9ff73
spl set id: 70f85a4a-d4d6-4863-bdb3-2ef8d85986e7

Reported adverse events (FAERS/openFDA)#

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