NDC | 45334-205-07, 45334-205-08 |
Set ID | 45e85a58-b21f-2ac7-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Pharmaceutical Specialties, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART358H |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients purified water, lauryl glucoside, coco-glucoside, acrylates copolymer, panthenol, pentylene glycol, glycerin, sucrose cocoate, disodium cocoyl glutamate, sodium cocoyl glycinate, behenyl alcohol, sucrose stearate, cetyl palmitate, sodium cocoyl glutamate, 1,2-hexanediol, sodium hydroxide, caprylyl glycol, sodium chloride
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FREE AND CLEAR
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45334-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 2 g in 100 mL Inactive Ingredients Ingredient Name Strength 1,2-HEXANEDIOL (UNII: TR046Y3K1G) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) SUCROSE COCOATE (UNII: 3H18P0UK73) SUCROSE STEARATE (UNII: 274KW0O50M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCO GLUCOSIDE (UNII: ICS790225B) SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM) WATER (UNII: 059QF0KO0R) DOCOSANOL (UNII: 9G1OE216XY) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERIN (UNII: PDC6A3C0OX) DEXPANTHENOL (UNII: 1O6C93RI7Z) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A) CETYL PALMITATE (UNII: 5ZA2S6B08X) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45334-205-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/02/2017 2 NDC:45334-205-07 7.4 mL in 1 TUBE; Type 0: Not a Combination Product 03/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 02/02/2017 Labeler - Pharmaceutical Specialties, Inc. (076499557) Establishment Name Address ID/FEI Business Operations Pharmaceutical Specialties, Inc. 076499557 manufacture(45334-205)