GUJIN BIO SERUM (GLYCERIN, ALLANTOIN, HYDROXYETHYLCELLULOSE) LIQUID [PHARMACAL INTERNATIONAL CO.,LTD.]

GUJIN BIO SERUM (GLYCERIN, ALLANTOIN, HYDROXYETHYLCELLULOSE) LIQUID [PHARMACAL INTERNATIONAL CO.,LTD.]
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NDC 24765-119-01
Set ID e71e0f0f-20bf-4419-8820-ef2c75be0f0d
Category HUMAN OTC DRUG LABEL
Packager Pharmacal International Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
  • GUJIN BIO SERUM

    GLYCERIN 3.5% 
    ALLANTOIN 0.05%
    HYDROXYETHYLCELLULOSE 0.05%

  • PURPOSE

    Relieves vaginal itch, burning and discharge

  • Indication and Usage

    For vaginal itch , burining relief

  • Dosage and Administration

    Apply liberally as needed, softly massage for absorption

  • Warnings

    ■ If following symptoms occur, stop use and consult a doctor: red spots,
    swelling, itching, irritation, or symptoms on applied skin under direct
    sunlight.
    ■ Do not use on scarred skin, or if you have dermatitis or eczema
    ■ Keep away from direct sunlight or heat

    ■ Keep out of reach of children
    ■ Follow the directions

    ■ Do not use during the pregnancy

  • INACTIVE INGREDIENT

    WATER, BUTYLENE GLYCOL, GLYCERIN, 1,2-HEXANEDIOL, PEG-60
    HYDROGENATED CASTOR OIL, LACTIC ACID, HYDROXYETHYLCELLULOSE,
    SODIUM LACTATE, HYDROXYETHYL
    ACRYLATE/SODIUMACRYLOYLDIMETHYL TAURATE COPOLYMER,
    CHLORPHENESIN, FRAGRANCE, L-ARGININE, ALLANTOIN, XANTHAN
    GUM, DISODIUM EDTA, CITRIC ACID, SIMMONDSIA CHINENSIS (JOJOBA)
    SEED OIL, SQUALANE, ROSA CENTIFOLIA FLOWER WATER, EUCALYPTUS
    GLOBULUS LEAF EXTRACT, ASPALATHUS LINEARIS EXTRACT,
    CHAMOMILLA RECUTITA (MATRICARIA)FLOWER/LEAF EXTRACT, ALOE
    BARBADENSIS LEAF EXTRACT, PENTYLENE GLYCOL, CAPRYLYL GLYCOL,
    LACTOBACILLUS/SOYBEAN FERMENT EXTRACT,
    SACCHAROMYCES/IMPERATA CYLINDRICA ROOTFERMENT EXTRACT,
    SACCHAROMYCES/VISCUM ALBUM (MISTLETOE)FERMENT EXTRACT,
    PHENOXYETHANOL, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT,
    LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT,
    EHTYLHEXYLGLYCERIN, ACETYL HEXAPEPTIDE-8

  • PRECAUTIONS

    ■ Keep out of reach of children

  • Produt Label

    product label

  • INGREDIENTS AND APPEARANCE
    GUJIN BIO SERUM 
    glycerin, allantoin, hydroxyethylcellulose liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN35 mg  in 1 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 mg  in 1 mL
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) (HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) - UNII:R33S7TK2EP) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ARGININE (UNII: 94ZLA3W45F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SQUALANE (UNII: GW89575KF9)  
    ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    VISCUM ALBUM FRUIT (UNII: P83EQ521R3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ROSEMARY (UNII: IJ67X351P9)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24765-119-013 mL in 1 TUBE; Type 0: Not a Combination Product06/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/07/2018
    Labeler - Pharmacal International Co.,Ltd. (557805060)
    Establishment
    NameAddressID/FEIBusiness Operations
    GreenCos Co., Ltd.694777325manufacture(24765-119)

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