NDC 76678-0001 Hwasamong Dr.all Scalp Healingshampoo

Betaine, Panthenol

NDC Product Code 76678-0001

NDC CODE: 76678-0001

Proprietary Name: Hwasamong Dr.all Scalp Healingshampoo 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: Betaine, Panthenol 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat high levels of a certain important body chemical (homocysteine) due to an inherited disorder (homocystinuria). Decreasing high homocysteine levels may help prevent serious blood clots, abnormal bone formation, brittle bones (osteoporosis), and eye problems (e.g., dislocated eye lens, nearsightedness). This medication works by decreasing blood levels of homocysteine. It does not correct the inherited disorder that causes the disease.

NDC Code Structure

  • 76678 - Eolracellbio Co., Ltd.
    • 76678-0001 - Hwasamong Dr.all Scalp Healingshampoo

NDC 76678-0001-1

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Hwasamong Dr.all Scalp Healingshampoo with NDC 76678-0001 is a a human over the counter drug product labeled by Eolracellbio Co., Ltd.. The generic name of Hwasamong Dr.all Scalp Healingshampoo is betaine, panthenol. The product's dosage form is shampoo and is administered via topical form.

Labeler Name: Eolracellbio Co., Ltd.

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.

Hwasamong Dr.all Scalp Healingshampoo 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.

  • BETAINE .5 g/100mL
  • PANTHENOL .3 g/100mL

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.

  • NIACINAMIDE (UNII: 25X51I8RD4)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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.
  • 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: Eolracellbio Co., Ltd.
Labeler Code: 76678
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-03-2020 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: 12-31-2021 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.

Hwasamong Dr.all Scalp Healingshampoo Product Label Images

Hwasamong Dr.all Scalp Healingshampoo 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

Biotin, panthenol

Otc - Purpose

Hair care, ph balanced shampoo

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

Warnings

■ For external use only.■ Do not use in eyes.■ lf swallowed, get medical help promptly.■ Stop use, ask doctor lf irritation occurs.■ Keep out of reach of children.

Dosage & Administration

For external use only

Inactive Ingredient

Water

Disodium Cocoamphodiacetate

Sodium Cocoyl Isethionate

Potassium Cocoyl Glycinate

Lauryl Glucoside

Decyl Glucoside

Glycerin

LoniceraJaponica(Honeysuckle)FlowerExtract

EcliptaProstrataExtract

CitrusUnshiuPeelExtract

MenthaArvensisExtract

PolygonumMultiflorumRootExtract

BiotaOrientalisLeafExtract

MorusAlbaLeafExtract

HouttuyniaCordataExtract

GlycineSoja(Soybean)SeedExtract

EckloniaCavaExtract

PerillaFrutescensLeafExtract

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Arginine

Polyquaternium-10

Allantoin

Niacinamide

Butylene Glycol

1,2-Hexanediol

Caprylyl Glycol

Illicium Verum (Anise) Fruit Extract

Citric Acid

Disodium EDTA

Sodium Hyaluronate

Zinc Pyrithione

Menthol

Fragrance

Indications & Usage

Combine hair before shampoo to remove large dustgently massage shampoo into wet hair and scalp all over your tipsrinse to remove any remaining dubblestap wet hair with a toweland let it dry in natural or cold wind

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