FDA.reportPublic FDA data

Diaper Rash

Manufacturer
GOODSENSE | Natureplex LLC
Effective date
2022-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:48

Label at a glance#

ProductDiaper Rash
Active ingredientZinc Oxide
Label structure11 sections

Indications and uses

helps treat and prevent diaper rash 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 allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Storage and handling

store at 15 to 30°C (59 to 86°F) Tamper Evident : DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with 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

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: 800-222-1222.

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 any time when exposure to wet diapers may be prolonged

Other information

STORAGE AND HANDLING SECTION

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, BHA, cetyl alcohol, coconut butter, corn starch, fragrance, hydroxyethylcellulose, lanolin, methylparaben, mineral oil, petrolatum, polysorbate 20, purified water, shea butter

SPL UNCLASSIFIED SECTION

Distributed by:
Perrigo Direct, Inc.
Peachtree City, GA 30269

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODSENSE®
NDC 50804-079-01

Maximum Strength

Diaper Rash Paste

40% Zinc Oxide

Soothes Burning
Prevents Diaper Rash
Protects Skin

NET WT 2 oz (56.7 g)

Compare to active ingredients of
Desitin® Maximum Strength*

Principal Display Panel - 56.7 g Tube Carton
Principal Display Panel - 56.7 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094560zinc oxide 40 % Topical PastePSN1
1094560zinc oxide 0.4 MG/MG PasteSCD1
1094560zinc oxide 40 % PasteSY1
1094560ZNO 0.4 MG/MG PasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50804-079-012025-01-30C16284748780-12cef2736-6cd1-d83d-e063-dadaa90ab31fDiaper Rash Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50804-079-01Diaper Rash1 in 1 CARTONPASTE11
50804-079-01Diaper Rash56.7 g in 1 TUBEPASTE56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-079DIAPER RASH (ZINC OXIDE) PASTE [GOODSENSE]1Legacy NDC, 2 package rows20220319_031be992-31b8-4a09-ba76-02d410073a93.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-079-01GM - Gram50804-079d9d46237-11ef-4b2f-84f4-694371ab673c12023-09-05

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50804-07950804-079-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Aloe Vera LeafZY81Z83H0XIACT
Butylated HydroxyanisoleREK4960K2UIACT
Cetyl Alcohol936JST6JCNIACT
Cocoa Butter512OYT1CRRIACT
Starch, CornO8232NY3SJIACT
Hydroxyethyl Cellulose, UnspecifiedT4V6TWG28DIACT
Lanolin7EV65EAW6HIACT
MethylparabenA2I8C7HI9TIACT
Mineral OilT5L8T28FGPIACT
Petrolatum4T6H12BN9UIACT
Polysorbate 207T1F30V5YHIACT
Water059QF0KO0RIACT
Shea ButterK49155WL9YIACT

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
96cb14c1-544f-48cc-bb1b-b014fbc7d36d031be992-31b8-4a09-ba76-02d410073a932022-03-17WarningsExact identifier
spl id: 96cb14c1-544f-48cc-bb1b-b014fbc7d36d
spl set id: 031be992-31b8-4a09-ba76-02d410073a93

Reported adverse events (FAERS/openFDA)#

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