Vitabath Baby Eczema Care Intensive Balm
FDA Label NDC 73172-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vitabath Inc. for the product Vitabath Baby Eczema Care Intensive Balm (NDC 73172-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Colloidal Oatmeal 1% w/w

Purpose

Skin protectant

Uses

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

Warnings

For external use only.

Otc - When Using

When using this product do not get into eyes.

Otc - Stop Use

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
right away..

Directions

Directions: Apply as needed.

Other Information

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

Inactive Ingredients

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

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