Lactomedi Self-care Trial Kit

Manufacturer
2359 US INC | isamogu Inc.
Effective date
2023-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:04

Label at a glance#

ProductLactomedi Self-care Trial Kit
Active ingredientLIMOSILACTOBACILLUS FERMENTUM ME-3
Label structure11 sections

Indications and uses

Maintain your natural pH balance and keep your intimate area moist.

Dosage and administration

After washing your hands, open the package, remove the cap, and apply it to the intimate area as if it were an injection. Take the tissue out of the pouch. Wipe the are from front to back. Throw tissue s in the toilet.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lactobacillus Ferment Lysate

Purposes

OTC - PURPOSE SECTION

BACTERIOSTATIC

Uses

INDICATIONS & USAGE SECTION

Maintain your natural pH balance and keep your intimate area moist.

Warnings

OTC - DO NOT USE SECTION

Do not use it on the part where you have a scar, eczema, or dermatitis.

Do not suitable for children under 3 years of age

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if
irritation, rash, red spot on the skin, or swelling occurs. These may be signs of a severe condition.

Warnings

OTC - WHEN USING SECTION

After opening the cap, use the product immediately and do not reuse it. Women in gestational periods should better not use it and not use it on the vulva just before delivery.

Women in gestational periods should better not use it and not use it on the vulva just before delivery.

Warnings

WARNINGS SECTION

After opening the cap, use the product immediately and do not reuse it.

Directions

DOSAGE & ADMINISTRATION SECTION

After washing your hands, open the package, remove the cap, and apply it to the intimate area as if it were an injection.

Take the tissue out of the pouch. Wipe the are from front to back. Throw tissue s in the toilet.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lactomedi Self-care Trial KitLactomedi Self-care Trial Kit

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83490-901-012024-07-30C16284748780-11030e365-02b8-111a-e063-dadaa90a10e283490-901 Lactomedi Self-care Trial Kit
83490-901-012024-01-30C16284748780-11030e365-02b8-111a-e063-dadaa90a10e283490-901 Lactomedi Self-care Trial Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82892-302-01Lactomedi Self-care Trial Kit90 g in 1 BOX, UNIT-DOSESWAB90 g in 1000.01 g in 100g1
82892-304-01Lactomedi Self-care Trial Kit18 g in 1 BOTTLE, PLASTICSOLUTION, GEL FORMING / DROPS1.8 g in 1000.025 g in 100g1
83490-901-01Lactomedi Self-care Trial Kit1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82892-302LACTOMEDI SELF-CARE TRIAL KIT (LACTOBACILLUS FERMENT LYSATE) KIT [2359 US INC]1Legacy NDC20230525_fa11836a-5aec-c4ec-e053-6394a90ac468.zip
82892-304LACTOMEDI SELF-CARE TRIAL KIT (LACTOBACILLUS FERMENT LYSATE) KIT [2359 US INC]1Legacy NDC20230525_fa11836a-5aec-c4ec-e053-6394a90ac468.zip
83490-901LACTOMEDI SELF-CARE TRIAL KIT (LACTOBACILLUS FERMENT LYSATE) KIT [2359 US INC]13 package rows20230525_fa11836a-5aec-c4ec-e053-6394a90ac468.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83490-90183490-901-01
82892-30282892-302-01
82892-30482892-304-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fa11836a-5aed-c4ec-e053-6394a90ac468fa11836a-5aec-c4ec-e053-6394a90ac4682023-04-24WarningsExact identifier
spl id: fa11836a-5aed-c4ec-e053-6394a90ac468
spl set id: fa11836a-5aec-c4ec-e053-6394a90ac468

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.