ALEVAI - ANTI DANDRUFF SCALP SERUM- zinc pyrithione cream

ALEVAI - ANTI DANDRUFF SCALP SERUM by

Drug Labeling and Warnings

ALEVAI - ANTI DANDRUFF SCALP SERUM by is a Otc medication manufactured, distributed, or labeled by ALEVAI PRODUCTS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Pyrithione 0.12%

PURPOSE

Anti-dandruff

USES:

For the relief of flaking and itching associated with dandruff.

WARNINGS

​For external use only.

WHEN USING

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

STOP USE AND ASK 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:

Shake well. Apply and massage directly into affected areas. Can be used in dry or damp hair. Do not Rinse off. For best results, use 1 to 4 times daily or as directed by a doctor.

INACTIVE INGREDIENT

Aqua, Polysorbate 20, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glycerin, Urtica Dioica (Nettle) Extract, Betula Alba Bark Extract, Juglans Regia (Walnut) Leaf Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Phenoxyethanol, Sodium Lactate, Sodium Gluconate, Benzyl Alcohol, Benzoic Acid, Sorbic Acid, Xanthan Gum, Aloe Barbadensis Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Allium Sativum Bulb Extract, Rosmarinus Officinalis (Rosemary) Oil, Sodium Hydroxide, Linalool, Limonene.

ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 1 FL OZ

ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 2 FL OZ

INGREDIENTS AND APPEARANCE

ALEVAI - ANTI DANDRUFF SCALP SERUM 
zinc pyrithione cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81457-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBIC ACID (UNII: X045WJ989B)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
ALLIUM SATIVUM WHOLE (UNII: IIF21WT8O3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROSEMARY OIL (UNII: 8LGU7VM393)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
SODIUM LACTATE (UNII: TU7HW0W0QT)
LAURETH-7 (UNII: Z95S6G8201)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM GLUCONATE (UNII: R6Q3791S76)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JUGLANS REGIA LEAF (UNII: 85HKB87105)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81457-012-01	1 in 1 BOX	04/17/2023
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 81457-012-02	1 in 1 BOX	04/17/2023
2		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M032	04/17/2023

Labeler - ALEVAI PRODUCTS LLC (117842557)