NDC 65112-262 Beauty And Health Research, Inc.

Dandruff Shampoo

NDC Product Code 65112-262

NDC 65112-262-01

Package Description: 227 g in 1 BOTTLE

NDC Product Information

Beauty And Health Research, Inc. with NDC 65112-262 is a a human over the counter drug product labeled by I Shay Cosmetics Inc. The generic name of Beauty And Health Research, Inc. is dandruff shampoo. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: I Shay Cosmetics Inc

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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.

Beauty And Health Research, Inc. 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.

  • PYRITHIONE ZINC 2 g/100g

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: I Shay Cosmetics Inc
Labeler Code: 65112
FDA Application Number: part358H 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: 01-18-2021 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: 12-31-2022 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.

Beauty And Health Research, Inc. Product Label Images

Beauty And Health Research, Inc. 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

Otc - Active Ingredient

Organic Colloidal Oatmeal 0.8% ... Skin Protectant

Otc - Purpose

Skin Protectant

Otc - Keep Out Of Reach Of Children

WARNING: Keep out of reach of children.

Indications & Usage

Temporarily protects and helps relieve minor skin irritation and itching due to:Eczema, rashes, insect bites, poison ivy, oak or sumac

Inactive Ingredient

Organic Safflower Oil, Organic Beeswax, Organic Rosehip Seed Oil, Organic Flax Oil, Vitamin E From Sunflowers, Organic Horsetail, Organic Comfrey, Organic Horsetail, Organic Aloe, Organic Calendula, Organic Burdock, Organic Licorice Root, Organic Chamomile, Organic St. John’s Wort, Organic Plantain.

Warnings

For external use only.Do not use on:

deep puncture wounds

serious burns

animal bites
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

Dosage & Administration

Apply as needed

* Please review the disclaimer below.