DANDRUFF- pyrithione zinc shampoo 
Xtreme Tools International, Inc

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.

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DANDRUFF SHAMPOO

Active Ingredient

Pyrithione zinc 2%

Purpose

Anti-dandruff

Use

Helps prevent itching and flaking associated with dandruff.

Warning

For external use only.

When using this product

Stop Use and ask a Doctor if

Keep out of reach of children. If swallowed get medical help, or contact a Poison Control Center right away.

Directions

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

Questions or comments?

Call 1-305-622-7474, Monday through Friday 9:00 AM to 5:00 PM

PACKAGE LABEL

473 mL in Bottle; NDC 74553-003-01

SHAMPOO

DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74553-003-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/06/2020
Labeler - Xtreme Tools International, Inc (125398904)
Registrant - Xtreme Tools International, Inc (125398904)
Establishment
NameAddressID/FEIBusiness Operations
Xtreme Tools International, Inc125398904manufacture(74553-003)

Revised: 10/2020
Document Id: b1bc4938-e945-2ba0-e053-2995a90a08bf
Set id: b0fab568-ffb8-2551-e053-2a95a90af23a
Version: 2
Effective Time: 20201015
 
Xtreme Tools International, Inc