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

ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER by

Drug Labeling and Warnings

ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER by is a Otc medication manufactured, distributed, or labeled by ALEVAI PRODUCTS LLC, CHEMCO CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

For the relief of the symptoms of dandruff and seborrheic dermatitis

INDICATIONS & USAGE

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

WARNINGS

For external use only.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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.

ASK DOCTOR

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

INACTIVE INGREDIENT

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 8OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 16OZ

ALEVAI - ANTI DANDRUFF CONDITIONER 32OZ

INGREDIENTS AND APPEARANCE

ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER 
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81457-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81457-002-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2021
2	NDC: 81457-002-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/16/2021
3	NDC: 81457-002-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2022
4	NDC: 81457-002-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M032	11/16/2021

Labeler - ALEVAI PRODUCTS LLC (117842557)

Registrant - CHEMCO CORPORATION (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMCO CORPORATION		032495954	manufacture(81457-002)