Label: LACTOMEDI SELF-CARE TRIAL KIT- lactobacillus ferment lysate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 82892-302-01, 82892-304-01, 83490-901-01 - Packager: 2359 US INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated April 24, 2023
If you are a consumer or patient please visit this version.
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- Active Ingredients
- Purposes
- Uses
- Warnings
- Warnings
- Warnings
- Warnings
- Warnings
- Directions
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Inactive Ingredients
Water, Butylene Glycol, Methylpropanediol, Hydroxyethylcellulose, Bifida Ferment Lysate, Camellia Sinensis Leaf Extract, Artemisia Princeps Leaf Extract, Centella Asiatica Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hippophae Rham- noides Fruit Extract, Chamomilla Recutita (Matricaria) Flower Extract, Tre- mella Fuciformis (Mushroom) Extract, Sodium Hyaluronate, Vincetoxicum Atratum Extract, Adenosine, Xanthan Gum, Propanediol, Hydroxyacetoph enone,1,2-Hexanediol, Dipotassium Glycyrrhizate, Citric Acid,Sodium Citr- ate, Dipropylene Glycol
1,2-Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Disodium Cocoamphodiace- tate, Sodium Chloride, Hexylene Glycol, Citric Acid, Butylene Glycol, Centella Asiatica Leaf Extract, Camellia Sinensis Leaf Extract, Artemisia Vulgaris Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hippophae Rhamnoides Extract, Melaleuca Alternifolia (Tea Tree) Extract, Water
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INGREDIENTS AND APPEARANCE
LACTOMEDI SELF-CARE TRIAL KIT
lactobacillus ferment lysate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83490-901 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83490-901-01 1 in 1 KIT; Type 0: Not a Combination Product 04/01/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOX, UNIT-DOSE 90 g in 100 Part 2 0 BOTTLE, PLASTIC 1.8 g in 100 Part 1 of 2 LACTO REMEDY LADYS CLEANSING WIPES
lactobacillus ferment lysate swabProduct Information Item Code (Source) NDC:82892-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIMOSILACTOBACILLUS FERMENTUM ME-3 (UNII: BQX4W45LG8) (LIMOSILACTOBACILLUS FERMENTUM ME-3 - UNII:BQX4W45LG8) LIMOSILACTOBACILLUS FERMENTUM ME-3 0.01 g in 100 g Inactive Ingredients Ingredient Name Strength CENTELLA ASIATICA LEAF (UNII: 6810070TYD) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) SODIUM CHLORIDE (UNII: 451W47IQ8X) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ) MELALEUCA ALTERNIFOLIA WHOLE (UNII: 976KV4FXYF) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82892-302-01 90 g in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2023 Part 2 of 2 LACTO REMEDY LADYS INNER CARE GEL
lactobacillus ferment lysate solution, gel forming / dropsProduct Information Item Code (Source) NDC:82892-304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIMOSILACTOBACILLUS FERMENTUM ME-3 (UNII: BQX4W45LG8) (LIMOSILACTOBACILLUS FERMENTUM ME-3 - UNII:BQX4W45LG8) LIMOSILACTOBACILLUS FERMENTUM ME-3 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU) VINCETOXICUM ATRATUM WHOLE (UNII: U3176B0S5J) XANTHAN GUM (UNII: TTV12P4NEE) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G) WATER (UNII: 059QF0KO0R) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) METHYLPROPANEDIOL (UNII: N8F53B3R4R) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) CHAMOMILE (UNII: FGL3685T2X) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) ACONITIC ACID (UNII: 93371T1BXP) SODIUM CITRATE (UNII: 1Q73Q2JULR) DIPROPYLENE GLYCOL (UNII: E107L85C40) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPANEDIOL (UNII: 5965N8W85T) ADENOSINE (UNII: K72T3FS567) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82892-304-01 18 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2023 Labeler - 2359 US INC (118974080) Registrant - 2359 US INC (118974080) Establishment Name Address ID/FEI Business Operations isamogu Inc. 695695834 manufacture(83490-901)
