Label: PSOCLEER ADVANCED PSORIASIS- salicylic acid cream
- NDC Code(s): 64058-211-34
- Packager: Concept Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active Ingredient
Salicylic Acid 2%Close
Psoriasis/Seborrheic Dermatitis TreatmentClose
Helps eliminate the symptoms associated with Psoriasis and/or Seborrheic Dermatitits including itching, scaling, flaking, redness, irritation of the skinClose
For external use only
Avoid contact with eyes
If eye contact occurs, rinse thoroughly with water
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.
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.Close
- Questions or Comments?
Call toll free 1-888-373-8831Close
- SPL UNCLASSIFIED SECTION
Concept Laboratories, Inc.
Chicago, IL 60642
- PRINCIPAL DISPLAY PANEL - 113g Bottle Label
with 2% Salicylic Acid
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 LABEL Item Code (Source) NDC:64058-211 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Salicylic Acid (Salicylic Acid) Salicylic Acid 2.26 g in 113 g Inactive Ingredients Ingredient Name Strength 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 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)