Label: LACTOMEDI FERMININE PROBIOTICS POWDER MIST- lactobacillus ferment lysate spray

  • 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 July 27, 2023

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  • Active Ingredients

    Lactobacillus Ferment Lysate 12.0%

  • Purposes

    Lactobacillus Ferment Lysate 12.0% ---------------- Bacteriostatic

  • Uses

    ■ balances pH and promotes vaginal health

  • Warnings

    Do not use the product to areas with scars, 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 spots on skin, or swelling occurs

  • Warnings

    • this product is for external use only
    • this product is not suitable for children under 3 years of age
    • keep out of direct sunlight

  • Warnings

    Do not use the product to areas with scars, eczema, or dermatitis.
    Ask a doctor or pharmacist before use if you are In later stage of pregnancy.
    When using this product
    • this product is for external use only
    • this product is not suitable for children under 3 years of age
    • keep out of direct sunlight
    Stop use and ask a doctor if irritation, rash, red spots on skin, or swelling occurs.
    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Shake 2-3 times before spraying on underwear, tampons, pads or directly on the vaginal area.
    Close the lid after use and always keep it at room temperature.

  • Inactive Ingredients

    White rice flour, Lactobacillus, Fructooligosaccharides, Hydrolyzed Silk, Bambusa Vulgaris Sap Extract

  • Label

    LACTOMEDI Ferminine Probiotics Powder Mist

  • INGREDIENTS AND APPEARANCE
    LACTOMEDI FERMININE PROBIOTICS POWDER MIST 
    lactobacillus ferment lysate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83490-318
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) (LIMOSILACTOBACILLUS FERMENTUM - UNII:2C1F12C6AP) LIMOSILACTOBACILLUS FERMENTUM12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6)  
    SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV)  
    LACTICASEIBACILLUS RHAMNOSUS (UNII: 9601IVB87J)  
    BAMBUSA VULGARIS SAP (UNII: 26W4035XBO)  
    WHITE RICE (UNII: A195V20H7A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83490-318-015 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2023
    Labeler - 2359 US INC (118974080)
    Registrant - 2359 US INC (118974080)
    Establishment
    NameAddressID/FEIBusiness Operations
    Isamogu Inc.695695834manufacture(83490-318)