NDC 73655-100 574h Cell Care

Zinc Pyrithione, Panthenol, Niacinamide, Biotin

NDC Product Code 73655-100

NDC 73655-100-02

Package Description: 1 BOTTLE in 1 CARTON > 300 mL in 1 BOTTLE (73655-100-01)

NDC Product Information

574h Cell Care with NDC 73655-100 is a a human over the counter drug product labeled by Celino Inc.. The generic name of 574h Cell Care is zinc pyrithione, panthenol, niacinamide, biotin. The product's dosage form is shampoo and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2375032.

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.

574h Cell Care 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)

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: Celino Inc.
Labeler Code: 73655
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: 06-01-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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574h Cell Care Product Label Images

574h Cell Care 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 Pyrithione 1.0 %Panthenol 0.5%Niacinamide 0.3%Biotin 0.06%

Inactive Ingredients

Water, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Sodium Cocoyl Glutamate, Acrylates Copolymer, Sodium Chloride, Dimethicone, Caprylic/Capric Triglyceride, Citric Acid, Tromethamine, Sodium Benzoate, Polyquaternium-10, Amodimethicone, Fragrance, Lithospermum Erythrorhizon Root Extract, Trideceth-12, Cetrimonium Chloride, Glycerin, PEG-30 Glyceryl Isostearate, Sodium Polynaphthalenesulfonate, Ceteth-20, Laureth-3, Laureth-5, Camellia Japonica Seed Oil, Human Cord Blood Cell Conditioned Media, Phenoxyethanol, Xanthan Gum, Rehmannia Glutinosa Root Extract, Cornus Officinalis Fruit Extract, Butylene Glycol, Alisma Orientale Tuber Extract, Dioscorea Japonica Root Extract, Poria Cocos Sclerotium Extract, Paeonia Suffruticosa Root Extract, 1,2-Hexanediol, Origanum Vulgare Leaf Extract, Mentha Viridis (Spearmint) Extract, Melissa Officinalis Extract, Chamomilla Recutita (Matricaria) Leaf Extract, Milk Protein Extract, Goat Milk Extract, Honey Extract, Propolis Extract, Polygala Tenuifolia Root Extract, Sigesbeckia Orientalis Extract, Ethylhexylglycerin

Purpose

Antidandruff, Anti-hair loss

Warnings

For external use only1. Stop using this product and see a dermatologist, if skin swelling, itching or skin rashes appear after using this product or by exposure to sun light2. Refrain from applying the product on wounded skin area3. Cautions during storage and handling a) keep out of reach from infants and children b) store away from direct sunlight4. Wash out immediately when in contact with eyes5. If not thoroughly rinsed off, this product can cause hair loss or discoloration

Keep Out Of Reach Of Children

Keep out of reach from infants and children

Uses

A hair shampoo containing primed human cord blood cell conditioned media whose performance in anti-hair loss is proved by clinical study+ Safety and efficacy proved in clinical trials+ Patent granted (Pat# 10-1836029)

Directions

1. Wet your scalp and hair with warm water.2. Press the pump 1-2 times to apply an appropriate amount in your palm.3. Massage gently into a lather for your scalp and hair with fingers.4. After 3 minutes of massage, rinse off thoroughly.

Questions

080-750-1800 www.celonia.co.kr

* Please review the disclaimer below.