NDC 73172-004 Vitabath Baby Soothing Relief Diaper Rash

Zinc Oxide

NDC Product Code 73172-004

NDC 73172-004-01

Package Description: 113 g in 1 TUBE

NDC Product Information

Vitabath Baby Soothing Relief Diaper Rash with NDC 73172-004 is a a human over the counter drug product labeled by Vitabath Inc.. The generic name of Vitabath Baby Soothing Relief Diaper Rash is zinc oxide. 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 Soothing Relief Diaper Rash 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.

  • ZINC OXIDE 14 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.


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 Soothing Relief Diaper Rash Product Label Images

Vitabath Baby Soothing Relief Diaper Rash 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

Zinc Oxide 14% w/w


Skin protectant


Uses: •helps treat and prevent diaper rash •protects

chafed skin due to diaper rash •helps seal out wetness


For external use only.

Otc - When Using

When using this product •avoid contact with eyes

When using this product •avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if •condition worsens or

does not improve within 7 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.

Dosage & Administration

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

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

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

* Please review the disclaimer below.