ALEVAI - STEM CELL ANTI DANDRUFF- pyrithione zinc shampoo 
ALEVAI PRODUCTS LLC

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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81457-020-04
81457-020-08
81457-020-16
81457-020-32

Pyrithione Zinc………………………………………………………………………………………. 2% Anti-dandruff

Use helps prevent recurrence of flaking and itching associated with dandruff.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

For external use only.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

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

Shake well. Wet hair. Massage shampoo into scalp. Rinse. Repeat if desired. For best results, use at least twice a week or as directed by a doctor. For maximum dandruff control, use every time you shampoo.

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Aqua, Sodium C14-16 Olefin Sulfonate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Methyl Gluceth-20, Cocamide MEA, Caprylyl Glycol, Hexylene Glycol, Parfum, Sodium Hydroxide, Polyquaternium-7, Mica, Titanium Dioxide, Silica, Iron Oxide, Tin Oxide, Propylene Glycol, Biotin, Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Sodium Benzoate, Camellia Sinensis Leaf Extract, Disodium EDTA, Hydrolyzed Keratin, Citric Acid, Panthenol, Argania Spinosa Kernel Oil, Cocos Nucifera Oil, Phenoxyethanol, FD&C Blue. 1 (CI 42090), Hexyl Cinnamal, Citral.

ALEVAI - ANTI DANDRUFF SHAMPOO 3.4OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 3.4OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 8OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 8OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 16OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 16OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 32OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 32OZ

ALEVAI - STEM CELL ANTI DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81457-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
ARGANIA SPINOSA WHOLE (UNII: 83K6O4FR76)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PANTHENOL (UNII: WV9CM0O67Z)  
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
BIOTIN (UNII: 6SO6U10H04)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81457-020-08226 g in 1 BOTTLE; Type 0: Not a Combination Product11/12/2021
2NDC:81457-020-16453 g in 1 BOTTLE; Type 0: Not a Combination Product11/12/2021
3NDC:81457-020-0496 g in 1 BOTTLE; Type 0: Not a Combination Product06/17/2022
4NDC:81457-020-32906 g in 1 BOTTLE; Type 0: Not a Combination Product06/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03211/12/2021
Labeler - ALEVAI PRODUCTS LLC (117842557)
Registrant - CHEMCO CORPORATION (032495954)
Establishment
NameAddressID/FEIBusiness Operations
CHEMCO CORPORATION032495954manufacture(81457-020)

Revised: 7/2022
Document Id: e3c4b2e7-c511-c4c8-e053-2995a90a78ae
Set id: d09b2fb8-c252-67b8-e053-2995a90a377a
Version: 6
Effective Time: 20220714
 
ALEVAI PRODUCTS LLC