Otc - Active Ingredient
Active Ingredient
Hydroquinone 2%
Essential Fade Complex
FDA Label NDC 59735-318
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biocosmetics Research Lab for the product Essential Fade Complex (NDC 59735-318). 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, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Skin Lightener Gel
Indications & Usage
Use For gradual fading of dark (brownish) spots.
Warnings
Warnings
Avoid contact with eyes. Children under 12 years of age: do not use unless directed by a doctor. Some users may experience a mild irritation. If skin irritation becomes severe, stop use and consult a doctor.
Dosage & Administration
Directions Apply a small amount as a thin layer on the affected area or use as directed by a doctor. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent or protective clothing in order to prevent darkening from reoccurring.
Inactive Ingredient
Other Ingredients
Water, Propylene Glycol, Cyclomethicone, Dimethiconol, Soybean (Glycine Soja) Oil, Ethylhexyl Cocoate, Butylene Glycol, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Dimethicone, Citrus Unshiu Peel Extract, Lecithin, Retinol, Glycolipids, Glycerin, Hydroxyethylcellulose, EDTA, Sodium Metabisulfite, Sodium Sulfite, Phenoxyethanol, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Fragrance, Yellow 5, Green 5.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Package Label.Principal Display Panel
Image Of Efadec (Efadec)
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