Aclaro PD Emulsion

Name: Aclaro PD Emulsion

Clinical Pharmacology

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3-(3,4-dihydroxyphenyl) alanine (dopa)1 and suppression of other melanocyte metabolic processes.2

Indications and Usage

Aclaro PD® is indicated for the gradual treatment of ultraviolet induced dyschromia and discoloration resulting from the use of oral contraceptives, pregnancy, hormone replacement therapy, or skin trauma.

Precautions


See Warnings


A. Pregnancy Category C: Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only when clearly indicated.

B. Nursing mothers: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when hydroquinone is used by a nursing mother.

C. Pediatric usage: Safety and effectiveness in pediatric patients below the age of 12 years have not been established.


Adverse Reactions

No systemic reactions have been reported. Occasional cutaneous hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately.

How Supplied

Aclaro PD® (hydroquinone USP 4%)bioadhesive emulsion is available in a: 1.5 ounce airless pump bottle NDC 68712-015-02

Store at controlled room temperature: 15˚-30˚ C (59˚–86˚ F)


Manufactured for:
Innocutis Holdings LLC
Charleston, SC 29401
Toll free: 1-800-499-4468
www.innocutis.com
www.Aclaro4.com
February 2011
U.S. Pat. No.: 5,942,243
ACLARO PD  HYDROQUINONE
hydroquinone emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68712-015
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroquinone (Hydroquinone) Hydroquinone 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID  
BENZYL ALCOHOL  
AVOBENZONE  
ALKYL (C12-15) BENZOATE  
CETEARYL ETHYLHEXANOATE  
CETYL ALCOHOL  
CETYL ESTERS WAX  
CETYL PALMITATE  
DIETHANOLAMINE CETYL PHOSPHATE  
DIMETHICONE  
EDETATE DISODIUM  
OCTINOXATE  
GLYCERIN  
GLYCOLIC ACID  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
PHENOXYETHANOL  
BUTYLATED HYDROXYANISOLE  
PROPYLENE GLYCOL  
CITRIC ACID MONOHYDRATE  
WATER  
SODIUM HYDROXIDE  
STEARIC ACID  
Packaging
# Item Code Package Description
1 NDC:68712-015-02 42.5 g in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/2011
Labeler - Innocutis Holdings LLC (071501252)
Establishment
Name Address ID/FEI Operations
Sonar Products 104283945 manufacture
Revised: 12/2011   Innocutis Holdings LLC
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