Active Ingredient
Active Ingredients: Tranexamic Acid 0.1%
The following Structured Product Label (SPL) was submitted to the FDA by Skin M.d. Korea for the product Pure Whitenol Serum (NDC 69629-010). 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 ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients: Tranexamic Acid 0.1%
Inactive Ingredients: Water, Butylene Glycerin, Octyldodecyl Myristate, Hydrogenated Poly(C6-14 Olefin), Limnanthes Alba (Meadowfoam) Seed Oil, Mineral Oil, Borago Officinalis Seed Oil, Rhodiola Sachalinensis Extract, Morus Alba Root Extract, Pentylene Glycol, Polysorbate 60, Glyceryl Stearate SE, Stearic Acid, Hydroxy-propyl Bispalmitamide MEA, Cyclopentasil-oxane, Dimethicone, Sorbitan Sesquioleate, Sorbitan Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasil-oxane, Dextrin, Lecithin, Isohexadecane, Caprylyl Glycol, Tocopheryl Acetate, Trehalose, Arginine, Polysorbate-80, 4-n-butylresorcinol, Squalane, Sodium Hyaluronate, Cetearyl Alcohol, Carbomer, BHT, Disodium EDTA, Fragrance(Parfum)
Purpose: Skin Protectant / Brightening
Warnings:
1. Discontinue use it the following symptoms occur. If symptoms are extreme consult a dermatologist.
1) Symptoms such as red dots, swollenness, itching, stimulation during use.
2) Symptoms such as the ones mentioned in 1) occur on the applied area.
2. Do not apply to parts of the skin that have rashes, are cut, or are infected.
3. Directions for storage and handling.
1) The lid must be closed after use.
2) Keep out of reach from children.
3) Store in a cool and dry place and avoid exposure to direct sunlight.
Keep out of reach of children: Keep out of reach of babies and children
Indications & Usage: For skin lightening. Apply adequate amount following the skin texture and gently tap to enhance absorption.
Dosage & Administration: Apply two times at morning and night onto the skin daily.
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