Label: LACTOMEDI PLEASURE GEL- lactobacillus ferment lysate gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 8, 2023

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  • Active Ingredients

    Lactobacillus Ferment Lysate 0.1%

  • Purposes

    Lactobacillus Ferment Lysate 0.1%-----------BACTERIOSTATIC

  • Uses

    For vaginal moisturization and protection

  • Warnings

    Do not use

    it on areas with open wounds, eczema, or dermatitis.

  • Warnings

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Warnings

    Stop use and ask a doctor if

    irritation, rash, red spot on the skin, or swelling occurs.

  • Warnings

    This product is for external use only.

    Women during menstruation and pregnancy are advised not to use the product

  • Directions

    Apply the product to the intended area as needed.

  • Inactive Ingredients

    Betula Alba Juice, Butylene Glycol, 1,2-Hexanediol, Sodium Hyaluronate, Snail Secretion Filtrate, Artemisia Princeps Leaf Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hippophae Rhamnoides Fruit Extract, Centella Asiatica Leaf Extract, Camellia Sinensis Leaf Extract, Allantoin, Centella Asiatica Extract, Hydroxyacetophenon, Sodium Polyacrylate, Carbomer, Hydroxyethylcellulose, Arginine, Propanediol, Citric Acid, Sodium Citrate, Water

  • Label

    LACTOMEDI Pleasure gel

  • INGREDIENTS AND APPEARANCE
    LACTOMEDI PLEASURE GEL 
    lactobacillus ferment lysate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83490-501
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) (LIMOSILACTOBACILLUS FERMENTUM - UNII:2C1F12C6AP) LIMOSILACTOBACILLUS FERMENTUM0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    ARGININE (UNII: 94ZLA3W45F)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    WATER (UNII: 059QF0KO0R)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BETULA PUBESCENS RESIN (UNII: 9G931M6I4G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83490-501-01150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/24/2023
    Labeler - 2359 US INC (118974080)
    Registrant - 2359 US INC (118974080)
    Establishment
    NameAddressID/FEIBusiness Operations
    isamogu Inc.695695834manufacture(83490-501)
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