Your browser does not support JavaScript! PSOCLEER ADVANCED PSORIASIS (SALICYLIC ACID) CREAM [CONCEPT LABORATORIES, INC.]
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PSOCLEER ADVANCED PSORIASIS (salicylic acid) cream
[Concept Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Psoriasis/Seborrheic Dermatitis Treatment

Indications

Helps eliminate the symptoms associated with Psoriasis and/or Seborrheic Dermatitits including itching, scaling, flaking, redness, irritation of the skin

Warnings

For external use only

Avoid contact with eyes

If eye contact occurs, rinse thoroughly with water

If pregnant or nursing, seek the advice of a health professional before using

When using this product use only as directed

If condition covers a large area of the body, consult your doctor before using this product

Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For Adults 18 years of age and older

Apply a small amount of cream in a downward motion to coat affected area one to four times daily or as directed by a doctor.

Inactive ingredients

Water (Aqua), Propylene Glycol, Glyceryl Stearate SE, Mineral Oil, Ceteareth-20, Glycerin, Cetearyl Alcohol, Stearic Acid, Sodium Hydroxide, DMDM Hydantoin, Methylparaben, Epilobium Angustofolium Flower/Leaf/Stem Extract, Melaleuca Alternifolia (Alfalfa) Extract, Arnica Montana Flower Extract, Propylparaben, Tocopheryl Acetate.

Questions or Comments?

Call toll free 1-888-373-8831

Manufactured by:
Concept Laboratories, Inc.
Chicago, IL 60642
www.conceptlabs.org

CL 9960

PRINCIPAL DISPLAY PANEL - 113g Bottle Label

SAFE AND
EFFECTIVE

PsoCleer
with 2% Salicylic Acid

ADVANCED

Psoriasis Cream

For Relief of Flaking, Scaling & Itching

net weight 4oz. (113g)

Principal Display Panel - 113g Bottle Label
PSOCLEER   ADVANCED PSORIASIS
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64058-211
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid2.26 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
GLYCERYL MONOSTEARATE 
MINERAL OIL 
STEARIC ACID 
ARNICA MONTANA FLOWER 
ALFALFA LEAF 
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP 
SODIUM HYDROXIDE 
DMDM HYDANTOIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-211-34113 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H01/08/2010
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-211)

Revised: 4/2013
 
Concept Laboratories, Inc.

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