Label: DANDRUFF- pyrithione zinc shampoo
- NDC Code(s): 74553-003-01
- Packager: Xtreme Tools International, 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 October 15, 2020
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- Active Ingredient
- Purpose
- Use
- Warning
- When using this product
- Stop Use and ask a Doctor if
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive Ingredients
Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Cocamide MEA, Glycol Distearate, Polysorbate 20,PPG-10 Cetyl Ether, PEG-8, Polyquaternium-10, Acrylates, Vinyl Neodecanoate, Crosspolymer, Hydrolyzed Wheat Protein, Ricinus Communis (Castor) Seed Oil, Hydrolyzed Keratin, Chitosan Succinamide, Argania Spinosa (Argan) Kemel Oil, Olea Europaea (Olive) Oil, Sodium Benzoate, Pottassium Sorbate, Fragrance, Citric Acid, CI 42090
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INGREDIENTS AND APPEARANCE
DANDRUFF
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74553-003 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 ARGAN OIL (UNII: 4V59G5UW9X) OLIVE OIL (UNII: 6UYK2W1W1E) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCOL DISTEARATE (UNII: 13W7MDN21W) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) COCO MONOETHANOLAMIDE (UNII: C80684146D) PPG-10 CETYL ETHER (UNII: Q056X4917J) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN (1000 MW) (UNII: 8V0I3U3HMO) POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981) ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) VINYL NEODECANOATE (UNII: 9NDY01YYPT) CASTOR OIL (UNII: D5340Y2I9G) CHITOSAN SUCCINAMIDE (1300 MPA.S) (UNII: 41164V2SNS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74553-003-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 10/06/2020 Labeler - Xtreme Tools International, Inc (125398904) Registrant - Xtreme Tools International, Inc (125398904) Establishment Name Address ID/FEI Business Operations Xtreme Tools International, Inc 125398904 manufacture(74553-003)
