Label: PSORIATAR (COAL TAR)- coal tar aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 75834-101-01 - Packager: Nivagen Pharmaceuticals, 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 May 5, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only
Do not use
- for prolonged periods without consulting a doctor
- this product in or around the rectum or in the genital area or groin except on the advice of a doctor
Ask a doctor or pharmacist before use if you are using the product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs.
When using this product
- avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
- use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
- Product can stain clothing, contact lenses and hair. To minimize staining, allow product to dry before contact.
- Directions
- Other Information
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Inactive Ingredients
Alcohol denatured, caprylic/capric triglyceride, ceteareth-20, cyclopentasiloxane, dimethicone, disodium edta, glycerin, hydroxypropyl methylcellulose, isobutane, isopropyl myristate, mentha piperita (peppermint) oil, phenoxyethanol, polysorbate 80, potassium sorbate, propane, sodium chloride, sodium citrate, stearic acid, water (aqua), xantham gum
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- PRINCIPAL DISPLAY PANEL - 100 g Can Label
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INGREDIENTS AND APPEARANCE
PSORIATAR (COAL TAR)
coal tar aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75834-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Coal Tar (UNII: R533ESO2EC) (Coal Tar - UNII:R533ESO2EC) Coal Tar 20 mg in 1 g Inactive Ingredients Ingredient Name Strength Isopropyl Alcohol (UNII: ND2M416302) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) Cyclomethicone 5 (UNII: 0THT5PCI0R) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Glycerin (UNII: PDC6A3C0OX) Hypromelloses (UNII: 3NXW29V3WO) Isobutane (UNII: BXR49TP611) Isopropyl Myristate (UNII: 0RE8K4LNJS) Peppermint Oil (UNII: AV092KU4JH) Phenoxyethanol (UNII: HIE492ZZ3T) Polysorbate 80 (UNII: 6OZP39ZG8H) Potassium Sorbate (UNII: 1VPU26JZZ4) Propane (UNII: T75W9911L6) Sodium Chloride (UNII: 451W47IQ8X) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Stearic Acid (UNII: 4ELV7Z65AP) Water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75834-101-01 1 in 1 CARTON 05/15/2016 1 100 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358H 05/15/2016 Labeler - Nivagen Pharmaceuticals, Inc. (052032418)