REJUVADERM MEDISPA FADING- hydroquinone lotion

Rejuvaderm medispa fading by

Drug Labeling and Warnings

Rejuvaderm medispa fading by is a Otc medication manufactured, distributed, or labeled by Ellen H Frankle MD Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: 2% hydroquinone

INACTIVE INGREDIENT

Also contains: Glycolic acid, Sodium metabisulfite, Kojic acid, Sodium Bisulfite.

INDICATIONS & USAGE

Use: lightens discolorations

DOSAGE & ADMINISTRATION

Directions: adults: apply a thin layer on the affected area twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may nt be noticeable when used on very dark skin. Avoid unnecessary sun exposure and use a sunscreen while using and after using this product to prevent darkening from reoccurring.

WARNINGS

Warnings: For External Use Only. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. some users of this product might experience a mild skin irritation.If skin irritation becomes severe, stop use and consult a doctor. Do not use on children under 12 years of age unless directed by a doctor. If
pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

GENERAL PRECAUTIONS

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

PURPOSE

Purpose: Skin Bleaching

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

Rejuvaderm Medispa

reawakens the essence that is you

Fading Lotion

2% hydroquinone

2 fl oz. (60 ml)

401944skin

wwwriskindoc.com

www.rejuvadermmedispa.com

INGREDIENTS AND APPEARANCE

REJUVADERM MEDISPA FADING 
hydroquinone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51325-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
hydroquinone (UNII: XV74C1N1AE) (hydroquinone - UNII:XV74C1N1AE)	hydroquinone	1.2 mL  in 60 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51325-300-03	60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	08/01/2010

Labeler - Ellen H Frankle MD Inc (603208240)