LACTOMEDI FERMININE PROBIOTICS POWDER MIST- lactobacillus ferment lysate spray 
2359 US INC

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.

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83490-318 LACTOMEDI Ferminine Probiotics Powder Mist

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

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)

Revised: 7/2023
Document Id: 0171c71c-4f03-4917-e063-6394a90a6d6e
Set id: 0171c71c-4f02-4917-e063-6394a90a6d6e
Version: 1
Effective Time: 20230727
 
2359 US INC