Label: MELATONIN SHEET MASK- glycerin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 8, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    Water, Aqua
    Scutellaria Baicalensis Root Extract
    Butylene Glycol
    Cyclomethicone
    Dimethicone
    Butyrospermum Parkii (Shea) Butter
    Silkworm Cocoon Extract
    Beeswax
    Persea Gratissima (Avocado) Oil
    Cetearyl Olivate
    Sorbitan Olivate
    Melatonin
    PEG-60 Hydrogenated Castor Oil
    Carbomer
    Triethanolamine
    Sodium Citrate
    Hydrolyzed Collagen
    Allantoin
    Glycyrrhiza Glabra (Licorice) Root Extract
    Zingiber Officinale (Ginger) Root Extract
    Schizandra Chinensis Fruit Extract
    Coptis japonica Extract
    Camellia Sinensis Leaf Extract
    Propolis Wax
    Asiaticoside
    Carrylyl glycol
    Citric Acid
    Sodium Polyacrylate
    Dipotassium Glycyrrhizate
    Xanthan Gum
    Polyquaternium-51
    Disodium EDTA
    Gold(1ppm)
    Lavandula Angustifolia (Lavender) Oil
    Cananga Odorata Leaf Oil

  • PURPOSE

    helps to hydrate and restore balance to your skin

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    before bed, cleanse and tone your skin

    apply and gently pross sheet mask onto skin

    remove sheet mask and lightly pat face to absorb remaining essence

  • WARNINGS

    For external use only.
    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MELATONIN SHEET MASK 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70812-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70812-004-0130 mL in 1 POUCH; Type 0: Not a Combination Product10/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34710/08/2020
    Labeler - BIOSTECH CO., LTD. (687294330)
    Registrant - BIOSTECH CO., LTD. (687294330)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOSTECH CO., LTD.687294330label(70812-004) , pack(70812-004) , manufacture(70812-004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!