FDA.reportPublic FDA data

Vitabath Baby Soothing Relief Diaper Rash Cream

Manufacturer
Vitabath Inc. | Canadian Custom Packaging Comapany
Effective date
2019-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:40

Label at a glance#

ProductVitabath Baby Soothing Relief Diaper Rash
Active ingredientZINC OXIDE
Label structure12 sections

Indications and uses

Uses : •helps treat and prevent diaper rash •protects chafed skin due to diaper rash •helps seal out wetness

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14% w/w

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Uses: •helps treat and prevent diaper rash •protects
chafed skin due to diaper rash •helps seal out wetness

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product •avoid contact with eyes

OTC - WHEN USING SECTION

When using this product •avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if •condition worsens or
does not improve within 7 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.

DOSAGE & ADMINISTRATION SECTION

Directions: Change wet or soiled diapers promptly.
Clean the diaper area and allow to dry. Apply cream
liberally as often as necessary, with each diaper change,
especially at bedtime or any time exposure to wet
diapers may be prolonged.

OTHER SAFETY INFORMATION

Other Information: •Remove quality seal. •Do not use if
quality seal is broken.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Helianthus Annuus (Sunflower)
Seed Oil, Beeswax white, Ricinus Communis (Castor)
Seed Oil, Butyrospermum Parkii (Shea) Butter, Cocos
Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit
Oil, Tocopherol, Salvia Sclarea (Clary) Oil, Simmondsia
Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape)
Seed Oil, Avena Sativa (Oat) Kernel Oil, Calophyllum
Inophyllum Seed Oil.

OTC - QUESTIONS SECTION

Questions? Call toll-free 1-888-673-3377

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube LabelTube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1546589zinc oxide 14 % Topical CreamPSN1
1546589zinc oxide 140 MG/ML Topical CreamSCD1
1546589zinc oxide 14 % Topical CreamSY1
1546589ZNO 140 MG/ML Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73172-004-012023-01-30C16284748780-1f386c64a-40a6-0266-e053-dadaa90a7c1aVitabath Baby Soothing Relief Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73172-004-01Vitabath Baby Soothing Relief Diaper Rash113 g in 1 TUBECREAM1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73172-004VITABATH BABY SOOTHING RELIEF DIAPER RASH (ZINC OXIDE) CREAM [VITABATH INC.]1Legacy NDC, 1 package rows20190614_8b3a3b17-67dd-7a13-e053-2995a90a099c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73172-00473172-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
TAMANU OILJT3LVK84A1IACT
GRAPE SEED OIL930MLC8XGGIACT
SUNFLOWER OIL3W1JG795YIIACT
WHITE WAX7G1J5DA97FIACT
CASTOR OILD5340Y2I9GIACT
SHEA BUTTERK49155WL9YIACT
OAT KERNEL OIL3UVP41R77RIACT
COCONUT OILQ9L0O73W7LIACT
OLIVE OIL6UYK2W1W1EIACT
TOCOPHEROLR0ZB2556P8IACT
CLARY SAGE OIL87L0D4U3M0IACT
JOJOBA OIL724GKU717MIACT
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
8b3a3875-de21-306f-e053-2a95a90a7ab88b3a3b17-67dd-7a13-e053-2995a90a099c2019-06-13WarningsExact identifier
spl id: 8b3a3875-de21-306f-e053-2a95a90a7ab8
spl set id: 8b3a3b17-67dd-7a13-e053-2995a90a099c

Reported adverse events (FAERS/openFDA)#

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