FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Rite Aid Corporation | Nice-Pak Products, LLC
Effective date
2026-01-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:35:46

Label at a glance#

ProductZinc Oxide
Active ingredientZINC OXIDE
Label structure13 sections

Indications and uses

• helps treat and prevent diaper rash • protects chafed skin due to the diaper rash and helps seal out wetness

Dosage and administration

• change wet and soiled diapers promptly • cleanse the diaper area • allow to dry • apply ointment 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 between 20⁰ and 25⁰C (68⁰ and 77⁰F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 40%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

• helps treat and prevent diaper rash
• protects chafed skin due to the 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 into 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

• change wet and soiled diapers promptly
• cleanse the diaper area
• allow to dry
• apply ointment 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 between 20⁰ and 25⁰C (68⁰ and 77⁰F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

Disclaimer

SPL UNCLASSIFIED SECTION

*This product not manufactured or disturbed by Johnson & Johnson Consumer Products Company, distributor of Desitin Maximum Strength Diaper Rash Paste.

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY:

RITE AID 

30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

SATISFACTION GUARENTEE

if you're not satisfied, we'll happily refund your money. 

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FREE FROM

PARABEN FREE

PHTHALATE FREE

NDC 11822-0534-1

MAXIMUM STRENGTH†

DIAPER RASH PASTE

40% ZINC OXIDE

Specially formulated for effective diaper rash care in a thick, rich formula

Helps heal, soothe & prevent diaper rash

Dye free

†MAXIMUM STRENGTH ZINC OXIDE DIAPER RASH OINTMENT AVAILABLE UNDER THE PRODOCT MONOGRAPH

Compare to the active ingredient in Destin ®Maximum Strength Original Ciaper Rash Paste*

NET WT 4OZ (113g)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244638zinc oxide 40 % Topical OintmentPSN5
244638zinc oxide 0.4 MG/MG Topical OintmentSCD5
244638zinc oxide 40 % Topical OintmentSY5
244638ZNO 0.4 MG/MG Topical OintmentSY5

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0534-1Zinc Oxide113 g in 1 TUBEOINTMENT1135
11822-0534-1Zinc Oxide1 in 1 PACKAGEOINTMENT15

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
11822-053411822-0534-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
COD LIVER OILBBL281NWFGIACT
LANOLIN7EV65EAW6HIACT
STARCH, CORNO8232NY3SJIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
YELLOW WAX2ZA36H0S2VIACT
TOCOPHEROLR0ZB2556P8IACT
ZINC OXIDESOI2LOH54ZACTIM
PETROLATUM4T6H12BN9UIACT

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 OXIDERite Aid Corporation3af9f0e5-0d79-4178-b29e-3b60735bf4ce2026-01-30Warnings, Adverse reactionsExact identifier
ndc (package): 11822-0534-1
ndc (product): 11822-0534
ndc11 (package): 11822053401
spl id: 499ed471-d111-2f4b-e063-6294a90ab925
spl set id: 3af9f0e5-0d79-4178-b29e-3b60735bf4ce

Reported adverse events (FAERS/openFDA)#

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