Aclaro Emulsion

Name: Aclaro Emulsion

Indications and Usage

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

Nursing Mothers

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.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Pediatric usage

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

Dosage and Administration

Apply Umecta topical suspension to affected skin twice per day or as directed by a physician. Rub in until completely absorbed.

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®(hydroquinone USP 4%) emulsion is available as follows:

1.7 ounce airless pump bottle NDC 68712-003-01

Store at controlled room temperature:15˚ - 25˚ C (59˚ – 77˚ F)

Manufactured for:
Innocutis Holdings, LLC.
Charleston, SC 29401
www.innocutis.com
www.Aclaro4.com
1. Denton C., Lerner A.B., and Fitzpatrick T.B. "Inhibition of Melanin Formation by Chemical Agents." Journal of Investigative Dermatology. 1952;18:119 - 135.

2. Jimbow K., Obata H., Pathak M., and Fitzpatrick T.B. "Mechanism of Depigmentation by Hydroquinone." Journal of Investigative Dermatology. 1974;62:436 - 449.
ACLARO   HYDROQUINONE
hydroquinone emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68712-003
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  
CETYL PHOSPHATE  
DIMETHICONE  
EDETATE DISODIUM  
OCTINOXATE  
GLYCERIN  
GLYCOLIC ACID  
SODIUM GLYCOLATE  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
PHENOXYETHANOL  
Water  
SODIUM METABISULFITE  
STEARIC ACID  
Packaging
# Item Code Package Description
1 NDC:68712-003-01 48.2 g in 1 BOTTLE, PUMP
2 NDC:68712-003-02 3 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2004
Labeler - Innocutis (071501252)
Establishment
Name Address ID/FEI Operations
Ei Inc. 105803274 manufacture
Revised: 11/2011   Innocutis
(web3)