NDC 73172-001 Vitabath Baby Eczema Care Moisture

Colloidal Oatmeal

NDC Product Code 73172-001

NDC 73172-001-01

Package Description: 226 g in 1 TUBE

NDC Product Information

Vitabath Baby Eczema Care Moisture with NDC 73172-001 is a a human over the counter drug product labeled by Vitabath, Inc.. The generic name of Vitabath Baby Eczema Care Moisture 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 Moisture 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.

  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • OAT (UNII: Z6J799EAJK)
  • OAT KERNEL OIL (UNII: 3UVP41R77R)
  • CERAMIDE NP (UNII: 4370DF050B)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DISTEARYLDIMONIUM (UNII: 251IW5I21C)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)

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: 06-11-2019 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 Moisture Product Label Images

Vitabath Baby Eczema Care Moisture 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 productAvoid contact with eyes

When using this product do not get into eyes.

Otc - Stop Use

  • Stop use and ask a doctor ifCONDITIONS WORSENSSYMPTOMS 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

Apply as needed.

Other Information:

•Remove quality seal •Do not use if quality seal is broken •For use on mild to moderate eczema or as directed by a physician •Store at room temperature

Inactive Ingredients

Purified water

Glycerin

Distearyldimonium Chloride

Isopropyl Palmitate

Ricinus communis (Castor) Seed Oil

Cetyl Alcohol

Diheptyl Succinate

Benzyl Alcohol

Capryloyl Glycerin/Sebacic Acid Copolymer

Sodium Hydroxide

Steareth-20

Hydrogenated Castor Oil

Benzoic Acid

Dl-Panthenol

Beeswax

Dehydroacetic Acid

Sodium Chloride

Copernicia Cerifera (Carnauba) Wax

Tocopherol

Avena Sativa (Oat) Kernel Extract

Avena Sativa (Oat) Kernel Oil

Ceramide NP

Otc - Questions

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

* Please review the disclaimer below.