FDA.reportPublic FDA data

Gentle Steps 226.002/226AD Creamy Diaper Rash Ointment

Manufacturer
OLD EAST MAIN CO | Consumer Product Partners, LLC
Effective date
2025-04-09
Label type
HUMAN OTC DRUG LABEL
Version
23
Source
legacy-cache
Hydrated at
2026-08-01 20:39:54

Label at a glance#

ProductDiaper Rash
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

change wet or 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 whn exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 13%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent daper rash
  • protects chafed skin due to 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 or 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 whn exposure to wet diapers may be prolonged

Other information

SPL UNCLASSIFIED SECTION

store between 20° and 25°C (68° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, mineral oil, petrolatum, beeswax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxystearate, Aloe barbadensis leaf juice, glycerin, tropolone, tocopheryl acetate, 1,2-hexanediol, caprylyl glycol, magnesium sulfate, potassium hydroxide, phenoxyethanol

ADVERSE REACTION

ADVERSE REACTIONS SECTION

100% Satisfaction Guaranteed!

(888) 309-9030

DISTRIBUTED BY

OLD EAST MAIN CO.

100 Mission Ridge

GOODLETTSVILLE, TN 37072

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentle Steps ®

ZINC OXIDE

DIAPER RASH CREAM

SKIN PROTECTANT

FREE FROM PARABENS, PHTHALATES & FRAGRANCES

hypoallergenic

pediatrician tested

NET WT 4 OZ (113 g)

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-826DIAPER RASH (ZINC OXIDE) CREAM [OLD EAST MAIN CO]23Legacy NDC20250410_dea32a36-49e8-4cf4-b48c-6e0f48779b2f.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-82655910-826-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
YELLOW WAX2ZA36H0S2VIACT
DIMETHICONE92RU3N3Y1OIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
TROPOLONE7L6DL16P1TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ZINC OXIDESOI2LOH54ZACTIB

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
49127ecf-7446-d693-e063-6394a90affb6dea32a36-49e8-4cf4-b48c-6e0f48779b2f2026-01-23Warnings, Adverse reactionsExact identifier
spl set id: dea32a36-49e8-4cf4-b48c-6e0f48779b2f

Reported adverse events (FAERS/openFDA)#

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