FDA.reportPublic FDA data

Diaper Rash Ointment

Manufacturer
Aldermed Inc.
Effective date
2026-05-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:36:46

Label at a glance#

ProductDiaper Rash
Active ingredientZINC OXIDE
Label structure9 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 anytime when exposure to wet diaper may be prolonged

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 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

  • Conditions 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 (1-800-222-1222).

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 anytime when exposure to wet diaper may be prolonged

Other information

OTHER SAFETY INFORMATION

■ to open: unscrew cap, pull tab to remove foil seal

■ may stain clothing

■ store at 15° to 30°C (59° to 86°F)

■ see tube crimp for lot number and expiration date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

beeswax, cod liver, fragrance, glycerin, lanolin, sorbitan sesquileate, talc, tocopheryl acetate, petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-833-605-84-74 9am-5 pm EST M-F

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
87236-01887236-018-04

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TALC7SEV7J4R1UIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
PETROLATUM4T6H12BN9UIACT
BEESWAX2ZA36H0S2VIACT
COD LIVER OILBBL281NWFGIACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-03full-release2026-06-01 01:48:48
12026-02-12monthly-update2026-06-03 17:56:31

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
Diaper RashZINC OXIDEAldermed Inc.4aa79292-dc91-b538-e063-6294a90ac3f02026-05-09WarningsExact identifier
ndc (package): 87236-018-04
ndc (product): 87236-018
ndc11 (package): 87236001804
spl id: 516cb310-3e44-00f5-e063-6294a90a4b8c
spl set id: 4aa79292-dc91-b538-e063-6294a90ac3f0

Reported adverse events (FAERS/openFDA)#

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