NDC 73172-003 Vitabath Baby Eczema Care Intensive Balm

Colloidal Oatmeal

NDC Product Code 73172-003

NDC Code: 73172-003

Proprietary Name: Vitabath Baby Eczema Care Intensive Balm What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Colloidal Oatmeal What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 73172 - Vitabath Inc.
    • 73172-003 - Vitabath Baby Eczema Care Intensive Balm

NDC 73172-003-01

Package Description: 312 g in 1 JAR

NDC Product Information

Vitabath Baby Eczema Care Intensive Balm with NDC 73172-003 is a a human over the counter drug product labeled by Vitabath Inc.. The generic name of Vitabath Baby Eczema Care Intensive Balm is colloidal oatmeal. The product's dosage form is cream and is administered via topical form.

Labeler Name: Vitabath Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Vitabath Baby Eczema Care Intensive Balm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OATMEAL 1 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • OAT (UNII: Z6J799EAJK)
  • CERAMIDE NP (UNII: 4370DF050B)
  • POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
  • DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Vitabath Inc.
Labeler Code: 73172
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-13-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Vitabath Baby Eczema Care Intensive Balm Product Label Images

Vitabath Baby Eczema Care Intensive Balm Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling 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

Otc - Questions

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

* Please review the disclaimer below.

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