Label: ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER- pyrithione zinc lotion
- NDC Code(s): 81457-002-04, 81457-002-08, 81457-002-16, 81457-002-32
- Packager: ALEVAI PRODUCTS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 14, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- ASK DOCTOR
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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
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INGREDIENTS AND APPEARANCE
ALEVAI – STEM CELL ANTI-DANDRUFF CONDITIONER
pyrithione zinc lotionProduct 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)
