ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER- pyrithione zinc lotion 
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.

----------

81457-002-04
81457-002-08
81457-002-16
81457-002-32

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

For the relief of the symptoms of dandruff and seborrheic dermatitis

Do not get into eyes. If contact occurs rinse eyes thoroughly with water.

For external use only.

Do not get into eyes. If contact occurs rinse eyes thoroughly with water.

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

For best results use at least twice a week or as directed by the doctor.

Apply a small amount quantity of the product into hair and massage the scalp.

Allow the product to act for 5 minutes.

Rinse thoroughly with water.

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

Aqua, Cetearyl Alcohol, Behentrimonium Methosulfate, Stearyl Alcohol, Cetyl Alcohol, Caprylic/Capric Triglyceride, Chlorophenesin, Caprylyl Glycol, Parfum, Organic Butyrospermum Parkii (Shea) Butter, Panthenol, Hydrolyzed Keratin, Hydroxypropyl Guar, Ricinus Communis (Castor) Seed Oil, Disodium EDTA, Propylene Glycol, Biotin, Argania Spinosa Kernel Oil, Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Sodium Benzoate, Glycerin, Algae Extract, Citric Acid, Phenoxyethanol, Cetrimonium Chloride, Hexyl Cinnamal, Citral.

ALEVAI - ANTI DANDRUFF CONDITIONER 3.4OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 3.4OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 8OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 8OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 16OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 16OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 32OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 32OZ

ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER 
pyrithione zinc lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81457-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
SHEA BUTTER (UNII: K49155WL9Y)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
BIOTIN (UNII: 6SO6U10H04)  
ARGANIA SPINOSA WHOLE (UNII: 83K6O4FR76)  
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
PANTHENOL (UNII: WV9CM0O67Z)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81457-002-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2021
2NDC:81457-002-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/16/2021
3NDC:81457-002-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2022
4NDC:81457-002-32946 mL 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 finalM03211/16/2021
Labeler - ALEVAI PRODUCTS LLC (117842557)
Registrant - CHEMCO CORPORATION (032495954)
Establishment
NameAddressID/FEIBusiness Operations
CHEMCO CORPORATION032495954manufacture(81457-002)

Revised: 7/2022
Document Id: e3c449cf-60b4-22f6-e053-2a95a90af0f9
Set id: d0eebc4c-5558-3332-e053-2995a90a5e96
Version: 6
Effective Time: 20220714
 
ALEVAI PRODUCTS LLC