Label: ALEVAI - STEM CELL ANTI DANDRUFF- pyrithione zinc shampoo
- NDC Code(s): 81457-020-04, 81457-020-08, 81457-020-16, 81457-020-32
- 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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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STOP USE
-
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
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INGREDIENTS AND APPEARANCE
ALEVAI - STEM CELL ANTI DANDRUFF
pyrithione zinc shampooProduct 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)