ALEVAI - STEM CELL ANTI DANDRUFF- pyrithione zinc shampoo

ALEVAI - STEM CELL ANTI DANDRUFF by

Drug Labeling and Warnings

ALEVAI - STEM CELL ANTI DANDRUFF 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

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

INDICATIONS & USAGE

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

WARNINGS

For external use only.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

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

INACTIVE INGREDIENT

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 8OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 16OZ

ALEVAI - ANTI DANDRUFF SHAMPOO 32OZ

INGREDIENTS AND APPEARANCE

ALEVAI - STEM CELL ANTI DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81457-020
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 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81457-020-08	226 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2021
2	NDC: 81457-020-16	453 g in 1 BOTTLE; Type 0: Not a Combination Product	11/12/2021
3	NDC: 81457-020-04	96 g in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2022
4	NDC: 81457-020-32	906 g 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	11/12/2021

Labeler - ALEVAI PRODUCTS LLC (117842557)

Registrant - CHEMCO CORPORATION (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMCO CORPORATION		032495954	manufacture(81457-020)