VANICREAM- pyrithione zinc shampoo Pharmaceutical Specialties, Inc. ---------- VANICREAM™ Dandruff Shampoo Drug Facts Active Ingredient Pyrithione zinc 2% Purposes Anti-dandruff, Anti-seborrheic dermatitis Uses Controls and reduces the symptoms of dandruff and seborrheic dermatitis Warnings For external use only Ask a doctor before use if you have a condition that covers a large area of the body. When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions For best results use at least twice a week or as directed by a doctor Shake before use Wet hair and massage gently into scalp Leave lather on scalp for several minutes Rinse well, repeat if needed Other information Store at room temperature 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? 1-800-325-8232 www.vanicream.com Dist. by PHARMACEUTICAL SPECIALTIES, INC. ROCHESTER, MN 55901 • Made in U.S.A. www.vanicream.com • 1-800-325-8232 NDC 45334-206-08 Formerly known as Free & Clear™ VANICREAM™ Pyrithione Zinc 2% Dandruff Shampoo for Sensitive Skin DERMATOLOGIST TESTED Free of dyes, fragrance, masking fragrance, lanolin, protein, parabens, & formaldehyde releasers Sulfate-free • Betaine-free • Gluten-free 8 fl oz (237 mL) VANICREAM pyrithione zinc shampoo Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45334-206 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ 5) (PYRITHIONE Z INC - UNII:R953O2RHZ 5) PYRITHIONE Z INC 2 g in 100 mL Inactive Ingredients Ingredient Name Strength Pharmaceutical Specialties, Inc. 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: 50C1307PZ G) GLYCERIN (UNII: PDC6A3C0OX) DEXPANTHENOL (UNII: 1O6C93RI7Z ) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A) CETYL PALMITATE (UNII: 5Z A2S6B08X) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ 3HG) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45334- 206-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/03/2022 2 NDC:45334- 206-07 7.4 mL in 1 TUBE; Type 0: Not a Combination Product 01/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M032 01/03/2022 Labeler - Pharmaceutical Specialties, Inc. (076499557) Establishment Name Address ID/FEI Business Operations Pharmaceutical Specialties , Inc. 076499557 manufacture(45334-206) Revised: 10/2023