Label: ZERNEL SCALP REJUVER ESSENCE- salicylic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 23, 2021

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  • Active ingredients

    Salicylic Acid 0.1%

  • Purpose

    Dandruff

  • Uses

    For prevention of hair loss, delivering nutrition to hair root and promotion of hair growth.

  • Warnings

    For external use only : wash it as soon as it gets into your eyes.

  • Keep out of reach of children

    Keep out of reach of children

  • Stop use and ask a doctor if

    irritation or rash occurs.

  • Do not use

    Stop using it if you have severe red spots or itching.

  • When using this product

    Do not use on wounded areas. Protein factors may clump over time, so be sure to shake before use. This is no problem with the product.

  • Directions

    After washing hair, shake and spray an appropriate amout to the hair removal scalp, massage until ubsorbed and dry hair slowly.

  • Other information

    Airtight container, Store at room temperature without sunlight/ after open keep it in the refrigerator.

  • Inactive ingredients

    Water, Glycerin, Alcohol, PEG-60 Hydrogenated Castor oil, Octyldodeceth-25, Betaine, l-Menthol, Caprylyl Glycol, Dexpanthenol, Disodium EDTA, Allantoin, Mentha Piperita (Peppermint) Oil, Glycine, Glutamic Acid, Lysine, Leucine, Alanine, Arginine, Isoleucine, Proline, Histidine, Cystine, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Linalool, Lavandula Hybrida Oil,, Eucalyptus Globulus Leaf Oil, Amaranthus Hypochondriacus Seed Extract, Chenopodium Quinoa Extract

  • Package Label

    80152-302-01

  • INGREDIENTS AND APPEARANCE
    ZERNEL SCALP REJUVER ESSENCE 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80152-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALANINE (UNII: OF5P57N2ZX)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    AMARANTHUS HYPOCHONDRIACUS SEED (UNII: TWW80P29UN)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GLYCINE (UNII: TE7660XO1C)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    HISTIDINE (UNII: 4QD397987E)  
    CYSTINE (UNII: 48TCX9A1VT)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WATER (UNII: 059QF0KO0R)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    OCTYLDODECETH-25 (UNII: F8934HEL3M)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BETAINE (UNII: 3SCV180C9W)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    LYSINE (UNII: K3Z4F929H6)  
    LEUCINE (UNII: GMW67QNF9C)  
    ARGININE (UNII: 94ZLA3W45F)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80152-302-01200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/07/2021
    Labeler - ZINOZEN CO., LTD. (695580488)
    Registrant - ZINOZEN CO., LTD. (695580488)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZINOZEN CO., LTD.695580488manufacture(80152-302)
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