FDA.reportPublic FDA data

Vitabath Baby Eczema Care Intensive Balm

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 Eczema Care Intensive Balm
Active ingredientOATMEAL
Label structure11 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: •Eczema • Rashes

Dosage and administration

Directions: Apply as needed.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1% w/w

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:
•Eczema • Rashes

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if • 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..

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Apply as needed.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other Information: •Remove quality seal. •Do not use if quality seal is broken. •Protect from
excessive heat (40°C/104°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water
Glycerin
Cetearyl Alcohol
Isopropyl Palmitate
Cetyl Alcohol
Caprylic/Capric Triglyceride
Sodium Stearoyl Glutamate
Stearic Acid
Benzyl Alcohol
Diheptyl Succinate
Potassium Phosphate Monobasic
Capryloyl Glycerin/Sebacic Acid Copolymer
Citric Acid
Sodium Hydroxide
Benzoic Acid
Dehydroacetic Acid
Tocopherol
Avena Sativa (Oat) Kernel Extract
Avena Sativa (Oat) Kernel Oil
Ceramide NP
Dipotassium Phosphate

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jar LabelJar Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN1
240651colloidal oatmeal 10 MG/ML Topical CreamSCD1
240651Avena sativa 1 % Topical CreamSY1
240651colloidal oatmeal 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73172-003-012023-01-30C16284748780-1f386c64a-13ed-0266-e053-dadaa90a7c1aVitabath Baby Eczema Care Intensive Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73172-003-01Vitabath Baby Eczema Care Intensive Balm312 g in 1 JARCREAM3121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73172-003VITABATH BABY ECZEMA CARE INTENSIVE BALM (COLLOIDAL OATMEAL) CREAM [VITABATH INC.]1Legacy NDC, 1 package rows20190614_8b35f8e3-a018-c5e9-e053-2a95a90aa03f.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73172-00373172-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
DEHYDROACETIC ACID2KAG279R6RIACT
TOCOPHEROLR0ZB2556P8IACT
OAT KERNEL OIL3UVP41R77RIACT
BENZOIC ACID8SKN0B0MIMIACT
OATZ6J799EAJKIACT
CERAMIDE NP4370DF050BIACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
STEARIC ACID4ELV7Z65APIACT
BENZYL ALCOHOLLKG8494WBHIACT
OATMEAL8PI54V663YACTIB

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
8b363dda-a524-f077-e053-2995a90af37a8b35f8e3-a018-c5e9-e053-2a95a90aa03f2019-06-13WarningsExact identifier
spl id: 8b363dda-a524-f077-e053-2995a90af37a
spl set id: 8b35f8e3-a018-c5e9-e053-2a95a90aa03f

Reported adverse events (FAERS/openFDA)#

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