LACTOMEDI PLEASURE GEL- lactobacillus ferment lysate gel 
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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83490-501 LACTOMEDI Pleasure gel

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

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)

Revised: 3/2023
Document Id: f6710434-c224-2b68-e053-2a95a90a06b5
Set id: f6710434-c223-2b68-e053-2a95a90a06b5
Version: 1
Effective Time: 20230308
 
2359 US INC