Label: 574H CELL CARE- zinc pyrithione, panthenol, niacinamide, biotin shampoo

  • NDC Code(s): 73655-100-01, 73655-100-02
  • Packager: Celino Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 19, 2020

If you are a consumer or patient please visit this version.

  • 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 only
    1. 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 light
    2. Refrain from applying the product on wounded skin area
    3. Cautions during storage and handling a) keep out of reach from infants and children b) store away from direct sunlight
    4. Wash out immediately when in contact with eyes
    5. 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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    574H CELL CARE 
    zinc pyrithione, panthenol, niacinamide, biotin shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73655-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC3.0 g  in 300 mL
    Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol1.5 g  in 300 mL
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.9 g  in 300 mL
    Biotin (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) Biotin0.18 g  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73655-100-021 in 1 CARTON06/01/2020
    1NDC:73655-100-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2020
    Labeler - Celino Inc. (695738827)
    Registrant - Celino Inc. (695738827)
    Establishment
    NameAddressID/FEIBusiness Operations
    Interkos Co.,Ltd.689850314manufacture(73655-100)