PSOCLEER  ADVANCED PSORIASIS- salicylic acid cream 
Concept Laboratories, Inc.

Disclaimer: 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.

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PsoCleer™
Advanced Psoriasis

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 DRUGItem Code (Source)NDC:64058-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2.26 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ALFALFA LEAF (UNII: HY3L927V6M)  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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
Document Id: ffc3a9b1-1c1a-4dab-8b31-167092cd09ec
Set id: 5973f754-429f-4412-aa6e-e39a7975ec4f
Version: 1
Effective Time: 20130425
 
Concept Laboratories, Inc.