ALEVAI - ANTI DANDRUFF SCALP SERUM- zinc pyrithione cream 
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.

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81457-012-01
81457-012-02

Zinc Pyrithione 0.12%

Anti-dandruff

USES:

For the relief of flaking and itching associated with dandruff.

​For external use only.

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.

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.

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 30

ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 2 FL OZ

ALEVAI STEM + ANTI-DANDRUFF SCALP SERUM 60

ALEVAI - ANTI DANDRUFF SCALP SERUM 
zinc pyrithione cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81457-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81457-012-011 in 1 BOX04/17/2023
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:81457-012-021 in 1 BOX04/17/2023
260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03204/17/2023
Labeler - ALEVAI PRODUCTS LLC (117842557)

Revised: 3/2023
Document Id: f6525731-c6c3-6355-e053-2a95a90a89f4
Set id: f6525731-c6c2-6355-e053-2a95a90a89f4
Version: 1
Effective Time: 20230307
 
ALEVAI PRODUCTS LLC