FDA.reportPublic FDA data

Baby Diaper Rash Cream

Manufacturer
Hello Bello
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:16:04

Label at a glance#

ProductBaby Diaper Rash Cream
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 and allow to dry. Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Drug Facts

DOSAGE & ADMINISTRATION SECTION

Drug Facts

Active Ingredients

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

OTC - STOP USE SECTION

if condition worsens or 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

INSTRUCTIONS FOR USE SECTION

  • Change wet and soiled diapers promptly.
  • Cleanse the diaper area and allow to dry.
  • Apply cream liberally as often as necessary, with each diaper change, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

OTHER SAFETY INFORMATION

  • Do not use if quality seal is broken
  • Do not store above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sunflower Seed Oil, Castor Seed Oil, Cera Alba (Beeswax), Cocos Nucifera Oil, Simmondsia Chinensis (Jojoba) Oil, Shea Butter, Tocopherol, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BDCRU 1BDCRU 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305337zinc oxide 40 % Topical CreamPSN1
1305337zinc oxide 400 MG/ML Topical CreamSCD1
1305337zinc oxide 40 % Topical CreamSY1
1305337ZNO 400 MG/ML Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73418-301-01Baby Diaper Rash Cream85 g in 1 TUBECREAM851
73418-301-01Baby Diaper Rash Cream1 in 1 CARTONCREAM11

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
73418-30173418-301-01

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
CITRIC ACID2968PHW8QPIACT
BEESWAX2ZA36H0S2VIACT
JOJOBA OIL724GKU717MIACT
SUNFLOWER OIL3W1JG795YIIACT
CASTOR OILD5340Y2I9GIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT OILQ9L0O73W7LIACT
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
Baby Diaper Rash CreamZINC OXIDEHello Bello42f14aa6-5694-7727-e063-6294a90a09f32025-11-06WarningsExact identifier
ndc (package): 73418-301-01
ndc (product): 73418-301
ndc11 (package): 73418030101
spl id: 42f13e3c-4743-fb30-e063-6394a90a8cfe
spl set id: 42f14aa6-5694-7727-e063-6294a90a09f3

Reported adverse events (FAERS/openFDA)#

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