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Name:Advanced Dual Complex Fademaximum Strength Plus
Manufacturer:Biocosmetic Research Labs
Category:Over-the-counter (OTC) Marketed Drugs


Advanced Dual Complex Fade Gel Maximum Strength Plus

ADVANCED DUAL COMPLEX FADE MAXIMUM STRENGTH PLUS - hydroquinone gel 
Biocosmetic Research Labs

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Advanced Dual Complex Fade Gel Maximum Strength Plus


Active Ingredient:

Hydroquinone 2%


Purpose:

Skin Lightening Gel


Uses:

For gradual fading of dark (brownish) spots


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.


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.


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)

Image of carton Advancedfadegelmax


ADVANCED DUAL COMPLEX FADE  MAXIMUM STRENGTH PLUS
hydroquinone gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-310
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 2 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59735-310-28 1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON contains a BOTTLE, PUMP
1 28.4 g in 1 BOTTLE, PUMP This package is contained within the CARTON (59735-310-28)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358 02/25/2009

Labeler - Biocosmetic Research Labs (078870292)

Revised: 02/2009 Biocosmetic Research Labs



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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