Aclaro PD description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Aclaro PD

Innocutis Holdings LLC

Aclaro PD


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Description



Aclaro PD



Clinical Pharmacology

Aclaro PD Indications and Usage

Contraindications

Aclaro PD® is contraindicated in any patient that has a prior history of hypersensitivity or allergic reaction to hydroquinone or any of the other ingredients. The safety of topical hydroquinone use during pregnancy or on
children (12 years and under) has not been established.

Warnings











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.


Side Effects

Overdosage

There have been no systemic reactions reported from the use of topical hydroquinone. However, treatment should be limited to relatively small areas of the body at one time, since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

Dosage and Administration

Aclaro PD® bioadhesive emulsion should be applied to the affected areas twice daily, or as directed by a physician. There is no recommended dosage for pediatric patients under 12 years of age except under the advice and supervision of a physician.

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)









Aclaro PD

Aclaro PD

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 40 mg

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 Marketing Start Date Marketing End Date
1 NDC:68712-015-02 42.5 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-04-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.