ALEVAI STEM CELL ANTI-DANDRUFF- pyrithione zinc solution

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Pyrithione Zinc 2%

Purpose

Anti-dandruff

Uses:

• Helps eliminate reoccurrence of sclap itching, irritation, redness, and falking associated with dandruff. 

Warnings:

For external use only

When using this product

• Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

• condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• For best results use at least twice a week or as directed by a doctor.
• Apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Other information:

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

Aqua (Deionized Water), PEG-80 Sorbitan Laurate, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Disodium Cocamidopropyl Betaine, Sodium Chloride, PEG-150 Distearate, Laureth-13 Carboxylate, Lauramine Oxide, Butylene Glycol, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Apigenin, Oleanolic Acid, Biotonyl Tripeptide-1, Argania Spinosa (Argan) oil, Serenoa Serrulata (Saw Palmetto) Extract, dl-Panthenol, Niacin, Biotin, Hydrolyzed Keratin Protein, L-Proline, Tocopheryl Acetate, Lamanaria Digitata (Sea Kelp) Extract, Spirulina Platensis (Spirulina) Extract, , Camellia Sinesis (Green Tea) Extract, Cocous Nucifera (Coconut) Oil, Malus Domestica (Apple) Fruit Cell Culture Extract, L-Leucine, L-Valine, Buddleja Davidii Meristem Cell Culture, Xanthan Gum, Crithmum Maritimum (Sea Fennel) Extract, Leontopodium Alpinum (Edelweiss) Stem Extarct, L-Threonine, Parfum (Fragrance), Phenoxyethanol, Ethylhexylglycerin

Package Labeling:

INGREDIENTS AND APPEARANCE

ALEVAI STEM CELL ANTI-DANDRUFF 
pyrithione zinc solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81457-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
APIGENIN (UNII: 7V515PI7F6)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)
ARGAN OIL (UNII: 4V59G5UW9X)
SAW PALMETTO (UNII: J7WWH9M8QS)
PANTHENOL (UNII: WV9CM0O67Z)
NIACIN (UNII: 2679MF687A)
BIOTIN (UNII: 6SO6U10H04)
PROLINE (UNII: 9DLQ4CIU6V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COCONUT OIL (UNII: Q9L0O73W7L)
APPLE (UNII: B423VGH5S9)
LEUCINE (UNII: GMW67QNF9C)
VALINE (UNII: HG18B9YRS7)
XANTHAN GUM (UNII: TTV12P4NEE)
CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)
THREONINE (UNII: 2ZD004190S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81457-124-00	236 mL in 1 CYLINDER; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	02/01/2021

Labeler - Alevai Products LLC (117842557)