FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Westminster Pharmaceuticals, LLC
Effective date
2025-07-08
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:06:41

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure10 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.

Storage and handling

store at 20-30°C (68-86 °F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

STORAGE AND HANDLING SECTION

  • store at 20-30°C (68-86 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, cetyl alcohol, glycerin, glyceryl stearate SE, isopropyl palmitate, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, tocopheryl acetate (vitamin E), stearyl alcohol, white petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-844-221-7294.

PRINCIPAL DISPLAY PANEL - 113 gram Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Soothing Aloe &
Vitamin E

NDC 69367-188-04

Zinc Oxide 22%

Daily Moisturizing
Diaper Rash Cream

Premium Skin Protectant

  • Helps Heal, Soothe & Prevent Diaper Rash
  • Protects Chafed Skin
  • Gentle on Sensitive Skin

NET WT: 4 oz (113 grams)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 113 gram Tube Label
PRINCIPAL DISPLAY PANEL - 113 gram Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1734937zinc oxide 22 % Topical CreamPSN9
1734937zinc oxide 220 MG/ML Topical CreamSCD9
1734937zinc oxide 22 % Topical CreamSY9
1734937ZNO 220 MG/ML Topical CreamSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-188-04Zinc Oxide113 g in 1 TUBECREAM1139

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-188-04GM - Gram69367-1880fb089c3-dbd3-4ce7-9f12-37882c9c1d4612022-01-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69367-18869367-188-04

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
CETYL ALCOHOL936JST6JCNIACT
MINERAL OILT5L8T28FGPIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PETROLATUM4T6H12BN9UIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PEG-100 MONOSTEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
Zinc OxideZINC OXIDEWestminster Pharmaceuticals, LLC7e045b3a-f33b-4faa-ab9b-2baec6ff79242025-07-08WarningsExact identifier
ndc (package): 69367-188-04
ndc (product): 69367-188
ndc11 (package): 69367018804
spl id: f9d7570e-1da1-4050-b2f1-72aeeb7359e3
spl set id: 7e045b3a-f33b-4faa-ab9b-2baec6ff7924

Reported adverse events (FAERS/openFDA)#

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