FDA.reportPublic FDA data

Natureplex Diaper Rash

Manufacturer
Natureplex LLC
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:10:56

Label at a glance#

ProductNatureplex Diaper Rash
Active ingredientZINC OXIDE
Label structure10 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

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natureplex™

Diaper Rash Cream
40% Zinc Oxide with Aloe
for
babies

NET WT. 1.5 Oz. (42.5g)

Principal Display Panel - 42.5 g Tube Box
Principal Display Panel - 42.5 g Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244638zinc oxide 40 % Topical OintmentPSN4
244638zinc oxide 0.4 MG/MG Topical OintmentSCD4
244638zinc oxide 40 % Topical OintmentSY4
244638ZNO 0.4 MG/MG Topical OintmentSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67234-001-012025-08-18C16284748780-12cef2736-977b-d83d-e063-dadaa90ab31fNatureplex™
67234-001-012025-01-30C16284748780-12cef2736-977b-d83d-e063-dadaa90ab31fNatureplex™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-001-01Natureplex Diaper Rash1 in 1 BOXCREAM14
67234-001-01Natureplex Diaper Rash42.5 g in 1 TUBECREAM42.54

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM621
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
67234-00167234-001-01

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 (100 MPA.S AT 2%)R33S7TK2EPIACT
LANOLIN7EV65EAW6HIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route
4 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii+dosage form
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route
4 equally ranked IID candidates

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
Natureplex Diaper RashZINC OXIDENatureplex LLC41fe8db3-727c-4bbe-a5ea-62efee4b97b02025-08-15WarningsExact identifier
ndc (package): 67234-001-01
ndc (product): 67234-001
ndc11 (package): 67234000101
spl id: 189abbf5-db87-4e18-bf9d-0e1601462df9
spl set id: 41fe8db3-727c-4bbe-a5ea-62efee4b97b0

Reported adverse events (FAERS/openFDA)#

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