83490-318 LACTOMEDI Ferminine Probiotics Powder Mist

LACTOMEDI Ferminine Probiotics Powder Mist by

Drug Labeling and Warnings

LACTOMEDI Ferminine Probiotics Powder Mist by is a Otc medication manufactured, distributed, or labeled by 2359 US INC, Isamogu Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 
lactobacillus ferment lysate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83490-318
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) (LIMOSILACTOBACILLUS FERMENTUM - UNII:2C1F12C6AP)	LIMOSILACTOBACILLUS FERMENTUM	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6)
SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV)
LACTICASEIBACILLUS RHAMNOSUS (UNII: 9601IVB87J)
WHITE RICE (UNII: A195V20H7A)
BAMBUSA VULGARIS SAP (UNII: 26W4035XBO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83490-318-01	5 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/31/2023	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/24/2023	07/29/2024

Labeler - 2359 US INC (118974080)

Registrant - 2359 US INC (118974080)

Establishment
Name	Address	ID/FEI	Business Operations
Isamogu Inc.		695695834	manufacture(83490-318)

Revised: 7/2024

Document Id: 1e63a206-a0f1-79e6-e063-6294a90aeab4

34390-5

Set id: 0171c71c-4f02-4917-e063-6394a90a6d6e

Version: 2

Effective Time: 20240729