Active Ingredients
Lactobacillus Ferment Lysate
Lactomedi Self-care Trial Kit
FDA Label NDC 83490-901
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 2359 Us Inc for the product Lactomedi Self-care Trial Kit (NDC 83490-901). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, directions, inactive ingredients, label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
BACTERIOSTATIC
Uses
Maintain your natural pH balance and keep your intimate area moist.
Warnings
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
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center immediately.
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.
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.
After opening the cap, use the product immediately and do not reuse it.
Directions
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
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
* Please review the disclaimer below.
