83490-317 LACTOMEDI Ferminine Soothing Cream

LACTOMEDI Ferminine Soothing Cream by

Drug Labeling and Warnings

LACTOMEDI Ferminine Soothing Cream 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 SOOTHING CREAM- lactobacillus ferment lysate, allantoin, panthenol cream 
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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83490-317 LACTOMEDI Ferminine Soothing Cream

Active Ingredients

Lactobacillus Ferment Lysate

Allantoin 0.1%

Panthenol 0.1%

Purposes

Lactobacillus Ferment Lysate 0.1%.....Bacteriostatic

Allantoin 0.1% ..................................Skin Protectant

Panthenol 0.1% ........................... External Analgesic

Uses

■ soothes and moisturizes irritated skin
■ 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

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

Warnings

Do not use the product to areas with scars, eczema, or dermatitis

Ask a doctor before use if you have
■ irritation
■ rash
■ red spots on skin
■ swelling

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

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Wash your hands and vulva and let dry. With your fingers, gently apply cream on the area that needs soothing or moisturizing.

Inactive Ingredients

Aqua, Hydrogenated Poly(C6-14 Olefin), Simmondsia Chinensis (Jojoba) Seed Oil,

Helianthus Annuus (Sunflower) Seed Oil, Xylitylglucoside, Diisostearyl Malate, Isocetyl Alcohol,

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol,

Anhydroxylitol, Xylitol, Caprylyl glycol, Xanthan Gum, Pentylene Glycol, Hydroxyacetophenone,

Glucose, Centella Asiatica Leaf Extract, Panthenol, Allantoin, Hamamelis Virginians (Witch Hazel) Leaf Extract,

Lactobacillus Ferment Lysate(1 .OOOpprn), Sorbit Isostearate, Ceramide NP, Camellia Sinensis Leaf Extract,

Artemisia Princeps Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hippophae Rhamnoides Fruit Extract,

1,2-Hexanediol, Sodium Hyaluronate, Hydroxypropyl trimonium Hyaluronate, Propolis Extract,

Centell Asiatica Extract, Zea Mays (Corn) Leaf Extract, Sodium Acetylated Hyaluronate, Hydrolyzed Hyaluronic Acid,

Hyaluronic Acid, Sodium Hyaluronate Crosspolymer, Hydrolyzed Sodium Hyaluronate, Potassium Hyaluronate

Label

LACTOMEDI FERMININE SOOTHING CREAM 
lactobacillus ferment lysate, allantoin, panthenol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83490-317
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) (LIMOSILACTOBACILLUS FERMENTUM - UNII:2C1F12C6AP)	LIMOSILACTOBACILLUS FERMENTUM	1 g  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	1 g  in 100 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONIC ACID (UNII: S270N0TRQY)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM (UNII: RWP5GA015D)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P)
ETHYL OLIVATE (UNII: KKJ108Y20W)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
FIBROBLAST GROWTH FACTOR-1 (UNII: G53298VN9Y)
ALANINE (UNII: OF5P57N2ZX)
WATER (UNII: 059QF0KO0R)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
JOJOBA OIL (UNII: 724GKU717M)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ISOCETYL ALCOHOL (UNII: 1800H64066)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
CERAMIDE NP (UNII: 4370DF050B)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CORN LEAF (UNII: LF3J87254C)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
XYLITOL (UNII: VCQ006KQ1E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83490-317-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	08/22/2023	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/22/2023	07/29/2024

Labeler - 2359 US INC (118974080)

Registrant - 2359 US INC (118974080)

Establishment
Name	Address	ID/FEI	Business Operations
Isamogu Inc.		695695834	manufacture(83490-317)

Revised: 7/2024

Document Id: 1e639851-3013-b4eb-e063-6294a90ada3a

34390-5

Set id: 0171c60a-1a15-c3ad-e063-6294a90a7262

Version: 3

Effective Time: 20240729