Label: MYCELLCARE- glycerin cream

  • NDC Code(s): 24765-105-01, 24765-105-02
  • Packager: Pharmacal-International. Co., Ltd.
  • 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 August 17, 2023

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  • ACTIVE INGREDIENT

    Glycerin 3.50%

  • PURPOSE

    Skin protectant

  • INDICATIONS & USAGE

    Relieves vaginal itch, burning and discharge

  • DOSAGE & ADMINISTRATION

    Apply liberally as needed, softly massage for absorption

  • WARNINGS

    For external use only

    Do not use on damaged or broken skin

    When using this product, keep out of eyes. Rinse with water to remove.

    Stop using and ask a doctor if rash, swelling, or irritation occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Human Stem Cell Conditioned Media, 1,2-Hexanediol, Lactic Acid, Hydroxyethylcellulose, Sodium Lactate, Peg-60 Hydrogenated Castor Oil, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl 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 Root Ferment Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Extract, Lavandula Angustifolia (Lavender) Flower Extract, Ehtylhexylglycerin, Acetyl Hexapeptide-8

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MYCELLCARE 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.175 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ARGININE (UNII: 94ZLA3W45F)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SQUALANE (UNII: GW89575KF9)  
    ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ROSEMARY (UNII: IJ67X351P9)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24765-105-028 in 1 BOX10/07/2016
    1NDC:24765-105-015 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/07/2016
    Labeler - Pharmacal-International. Co., Ltd. (557805060)
    Registrant - Pharmacal-International. Co., Ltd. (557805060)
    Establishment
    NameAddressID/FEIBusiness Operations
    EcoWorldpharm Co., Ltd.688735061manufacture(24765-105)