The following Structured Product Label (SPL) was submitted to the FDA by Vs Shinbi Co., Ltd. for the product U-max Whitening Functional Essence (NDC 50795-3001). 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 otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredient: allantoin
Inactive Ingredient
Inactive ingredient: water, glycerin, propylene glycol, arbutin, disodium EDTA, tocopheryl acetate, carbomer, caprylic triglyceride, petrolatum, stearic acid, cetearyl alcohol, glyceryl stearate, sorbitan stearate, houttuynia cordata extract, saururus chinensis extract, xanthium strumarium fruit extract, solanum lycopersicum fruit extract, eclipta prostrata leaf extract, angelica gigas root extract, glycyrrhiza glabra root extract, camellia sinensis leaf extract, hydrolyzed soybean extract, artemisia vulgaris extract, perfume, portulaca oleracea extract, salicornia herbacea extract, laminaria japonica extract, taraxacum officinale leaf extract, morus bombycis leaf extract, poria cocos extract, eucommia ulmoides leaf extract, citrus paradisi seed oil, ubiquinone, biosaccharide gum-1, hydroxypropyl methylcellulose, iron titanium oxide, cellulose
Otc - Purpose
Skin whitening
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children
Indications & Usage
- apply only for skin- apply 2 or 3 times a day with 5~6ml- massage with your finger over 2 min and let them dry
Warnings
- keep out of eyes, ears and mouth- if contact occurs, rinse away with plenty of cold water
Dosage & Administration
- for external use only
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