NDC | 42851-072-01 |
Set ID | e9df51c5-d681-496b-b1ef-3c4e7b84be29 |
Category | HUMAN OTC DRUG LABEL |
Packager | ZO Skin Health, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333D |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- Other Information
-
Inactive ingredients
Water (Aqua), SD Alcohol 40-B (Alcohol Denat.), PEG-8, Dimethicone, Arbutin, PVM/MA Decadiene Crosspolymer, Aminopropyl Kojyl Phosphate, Pentylene Glycol, Glycerin, Sodium Hydroxide, Aminopropyl Dihydrogen Phosphate, Acetyl Glucosamine, Dimethicone/PEG-10/15 Crosspolymer, Trisiloxane, Helianthus Annuus Seed Oil, Prunus Amygdalus Dulcis Oleosomes, Mel Extract, Trimethylsiloxysilicate/Dimethiconol Crosspolymer, Alcohol, Brassica Oleracea Italica Extract, Glutathione, Sodium Sulfite, Polysorbate 80, Lecithin, Soy Isoflavones.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
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INGREDIENTS AND APPEARANCE
ZO MEDICAL AKNEBRIGHT ACNE SPOT AND PIGMENTATION TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-072 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) DIMETHICONE (UNII: 92RU3N3Y1O) ARBUTIN (UNII: C5INA23HXF) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V) N-ACETYLGLUCOSAMINE (UNII: V956696549) TRISILOXANE (UNII: 9G1ZW13R0G) SUNFLOWER OIL (UNII: 3W1JG795YI) BARLEY MALT SYRUP (UNII: 22P8DKP670) GLUTATHIONE (UNII: GAN16C9B8O) SODIUM SULFITE (UNII: VTK01UQK3G) POLYSORBATE 80 (UNII: 6OZP39ZG8H) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) SOY ISOFLAVONES (UNII: 71B37NR06D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-072-01 1 in 1 CARTON 1 15 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 11/03/2014 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations PAKLAB 790530976 MANUFACTURE(42851-072)