PSOCLEER ADVANCED PSORIASIS- salicylic acid cream

PsoCleer by

Drug Labeling and Warnings

PsoCleer by is a Otc medication manufactured, distributed, or labeled by Concept Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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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)

INGREDIENTS AND APPEARANCE

PSOCLEER   ADVANCED PSORIASIS
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64058-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2.26 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64058-211-34	113 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	01/08/2010

Labeler - Concept Laboratories, Inc. (962282612)

Establishment
Name	Address	ID/FEI	Business Operations
Concept Laboratories, Inc.		962282612	MANUFACTURE(64058-211)