NDC | 42851-076-02 |
Set ID | 3e8375e6-9420-4226-b258-e3cda364da16 |
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
-
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
Euphorbia Cerifera (Candelilla) Cera, Beeswax, Polyethylene, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Phenyl Trimethicone, Polybutene, Octyldodecanol, Tridecyl Stearate, Neopentyl Glycol, Dicaprylate/Dicaprate, Cellulose, Disteardimonium Hectorite, Polyglyceryl-10 Heptahydroxystearate, Silica, Helianthus Annuus (Sunflower) Seed Oil, Oleyl Alcohol, Propylene Carbonate, Water, Tridecyl Trimellitate, Triethyl Citrate, Glycerin, Zanthoxylum Bungeanum Fruit Extract, Jojoba Esters, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Ceramide NG, Trihydroxystearin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Alumina, Marrubium Vulgare Meristem Cell Culture, Leontopodium Alpinum Meristem Cell Culture, Honey, Phenoxyethanol, Lecithin, Sodium Benzoate, Titanium Dioxide, Iron Oxides.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 2.3 g Applicator Carton
-
INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH OFFECTS CORRECT AND CONCEAL ACNE TREATMENT (LIGHT)
salicylic acid stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-076 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 g Inactive Ingredients Ingredient Name Strength CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) TRIDECYL STEARATE (UNII: A8OE252M6L) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) OCTYLDODECANOL (UNII: 461N1O614Y) POWDERED CELLULOSE (UNII: SMD1X3XO9M) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUNFLOWER OIL (UNII: 3W1JG795YI) OLEYL ALCOHOL (UNII: 172F2WN8DV) PROPYLENE CARBONATE (UNII: 8D08K3S51E) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418) TEA TREE OIL (UNII: VIF565UC2G) JOJOBA BUTTER (UNII: XIA46H803R) CERAMIDE NG (UNII: C04977SRJ5) ROSEMARY (UNII: IJ67X351P9) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) ALUMINUM OXIDE (UNII: LMI26O6933) HONEY (UNII: Y9H1V576FH) PHENOXYETHANOL (UNII: HIE492ZZ3T) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) SODIUM BENZOATE (UNII: OJ245FE5EU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-076-02 1 in 1 CARTON 01/01/2016 1 2.3 g in 1 APPLICATOR; 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 01/01/2016 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Hudson Cosmetics MFG Corp. DBA: Paramount Cosmetics, Inc. 001321058 MANUFACTURE(42851-076)