83490-501 LACTOMEDI Pleasure gel

LACTOMEDI Pleasure gel by

Drug Labeling and Warnings

LACTOMEDI Pleasure gel 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 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 
lactobacillus ferment lysate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83490-501
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) (LIMOSILACTOBACILLUS FERMENTUM - UNII:2C1F12C6AP)	LIMOSILACTOBACILLUS FERMENTUM	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83490-501-01	150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/24/2023	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/24/2023	07/29/2024

Labeler - 2359 US INC (118974080)

Registrant - 2359 US INC (118974080)

Establishment
Name	Address	ID/FEI	Business Operations
isamogu Inc.		695695834	manufacture(83490-501)

Revised: 7/2024

Document Id: 1e63a9ab-c36b-c89b-e063-6394a90a6930

34390-5

Set id: f6710434-c223-2b68-e053-2a95a90a06b5

Version: 2

Effective Time: 20240729