Label: PSOCLEER ADVANCED PSORIASIS- salicylic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64058-211-34 - Packager: Concept Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 25, 2013
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Indications
- Warnings
- Directions
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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.
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113g Bottle Label
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INGREDIENTS AND APPEARANCE
PSOCLEER ADVANCED PSORIASIS
salicylic acid creamProduct 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)