Otc - Active Ingredient
Active Ingredient:
Hydroquinone 2%
Advanced Dual Complex Fade
FDA Label NDC 59735-310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biocosmetic Research Labs for the product Advanced Dual Complex Fade (NDC 59735-310). 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, otc - stop use, dosage & administration, inactive ingredient, 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 Lightening Gel
Indications & Usage
Uses:
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.
Otc - Stop Use
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 or a sun blocking agent.
Inactive Ingredient
Other Ingredients:
Water, Propylene Glycol, Carbomer, Sodium Palmitoyl Proline, Nymphaea Alba Flower Extract, glycerin, Citrus Unshiu Peel Extract, Sodium Hydroxymethylglycinate,Sodium Sulfite, Sodium Metabisulfite, Butylene Glycol, Phenoxyethanol, Disodium EDTA, Polysorbate 20, Trisodium EDTA, Benzophenone-4, EDTA, Caprylyl Glycol, Hexylene Glycol, Sodium Hydroxide, Caramel, Mica, Iron Oxides (CI 77491)
Package Label.Principal Display Panel
Image Of Carton Advancedfadegelmax (Advancedfadegelmax)
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