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Drug Facts
Manufactured by:
Concept Laboratories, Inc.
Chicago, IL 60642
www.conceptlabs.org
CL 9960
Psocleer
FDA Label NDC 64058-211
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Concept Laboratories, Inc. for the product Psocleer (NDC 64058-211). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, indications, warnings, otc - pregnancy or breast feeding, otc - when using, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Pregnancy Or Breast Feeding
If pregnant or nursing, seek the advice of a health professional before using
Otc - When Using
When using this product use only as directed
Otc - Ask Doctor
If condition covers a large area of the body, consult your doctor before using this product
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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?
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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)
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