Label: RED SERUM- witch hazel gel

  • 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 18, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient Hamamelis Virginiana (Witch Hazel) Leaf Extract 2.5%

  • PURPOSE

    Purpose Skin Protectant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indication and Usage

    Apply to the entire face and neck after face wash and toner. Follow with moisturizer. For both day and night.

  • DOSAGE & ADMINISTRATION

    Dosage and Administration

    Apply 2~4 drops at a time, smoothing in gently.

  • WARNINGS

    Warnings

    1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist.

    1) In case of having problems such as red spots, swelling, itching or irritation during using this product.

    2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight.

    2. Do not use it on the part where you have a scar, eczema or dermatitis.

    3. For external use only.

  • INACTIVE INGREDIENT

    Inactive Ingredient

    water, butylene glycol, glycerin, sodium hyaluronate, betaine, punica granatum fruit extract, vaccinium angustifolium (blueberry) fruit extract, rubus chamaemorus fruit extract, lycium chinense fruit extract, rubus idaeus (raspberry) fruit extract, euterpe oleracea fruit extract, lepidium sativum sprout extract, niacinamide, dioscorea opposita (wild yam) root extract, 1,2-hexanediol, caprylyl glycol, capylhydroxamic acid, boswellia, serrata resin extract, prunus amygdalus dulcis (sweet almond) seed extract, PEG-60 hydrogenated castor oil, allantoin, carbomer, arginine, dipotassium glycyrrhizate, adenosine, jasminum officinale (jasmine) oil, disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RED SERUM 
    witch hazel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69457-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BETAINE (UNII: 3SCV180C9W)  
    PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)  
    VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW)  
    RUBUS CHAMAEMORUS FRUIT (UNII: 74CW8G72Q6)  
    LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)  
    RUBUS IDAEUS FRUIT VOLATILE OIL (UNII: 276X2YNL0K)  
    EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
    LEPIDIUM SATIVUM LEAF (UNII: 2ML4POY35W)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIOSCOREA OPPOSITIFOLIA WHOLE (UNII: KZY1A7K8MD)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ARGININE (UNII: 94ZLA3W45F)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ADENOSINE (UNII: K72T3FS567)  
    JASMINUM OFFICINALE WHOLE (UNII: X3314B4SYD)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69457-000-0040 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/18/2015
    Labeler - LAB & Company Inc. (688284779)
    Establishment
    NameAddressID/FEIBusiness Operations
    LAB & Company Inc.688284779manufacture(69457-000)