Label: NIOXIN SCALP RECOVERY MEDICATING CLEANSER- pyrithione zinc shampoo
- NDC Code(s): 82157-003-20
- Packager: Wella Operations US 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 December 2, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients water, sodium laureth sulfate, PEG-3 distearate, sodium laureth-8 sulfate, sodium chloride, cocamidopropyl betaine, acrylates/steareth-20 methacrylate copolymer, magnesium laureth-8 sulfate, magnesium laureth sulfate, sodium oleth sulfate, fragrance, sodium benzoate, citric acid, DMDM hydantoin, mentha arvensis leaf oil, mentha piperita (peppermint) oil, magnesium oleth sulfate, sodium hydroxide, polyquaternium-10, propylene glycol, benzoic acid, linalool, hexyl cinnamal, camellia sinensis leaf extract, sodium polynaphthalenesulfonate, benzyl alcohol, limonene, geraniol, cellulose gum, yeast extract, niacinamide, tocopheryl acetate, panthenol, biotin, lecithin, ethoxydiglycol, maltodextrin, methylparaben, glucose, propylparaben, lactic acid, achillea millefolium extract, betula alba leaf extract, urtica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, tartaric acid, caramel.
- QUESTIONS
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SPL UNCLASSIFIED SECTION
NIOXIN SCALP RECOVERY®
MEDICATING CLEANSER
IS AN ANTIDANDRUFF SHAMPOO WITH PYRITHIONE ZINC THAT HELPS PREVENT AND RELIEVE THE SYMPTOMS OF DANDRUFF, SUCH AS SCALP ITCHING AND FLAKING.
MADE IN U.S.A. of U.S. and/or imported ingredients
Dist. Wella Operations US LLC, Calabasas, CA 91302
www.nioxin.com
1-800-935-5273
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INGREDIENTS AND APPEARANCE
NIOXIN SCALP RECOVERY MEDICATING CLEANSER
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82157-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 1 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS) FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) (UNII: 90D834OZUI) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LIMONENE, (+/-)- (UNII: 9MC3I34447) SODIUM OLEYL SULFATE (UNII: 46F21X4586) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N) MAGNESIUM LAURETH-8 SULFATE (UNII: 2OTJ9LF5UA) MAGNESIUM LAURETH SULFATE (UNII: UKW9G007TZ) SODIUM HYDROXIDE (UNII: 55X04QC32I) BIOTIN (UNII: 6SO6U10H04) SODIUM LAURETH-8 SULFATE (UNII: YP8U3694P0) GERANIOL (UNII: L837108USY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ROSEMARY (UNII: IJ67X351P9) INOSITOL (UNII: 4L6452S749) LACTIC ACID (UNII: 33X04XA5AT) BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SAGE (UNII: 065C5D077J) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) BENZOIC ACID (UNII: 8SKN0B0MIM) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) MALTODEXTRIN (UNII: 7CVR7L4A2D) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E) TARTARIC ACID (UNII: W4888I119H) CARAMEL (UNII: T9D99G2B1R) PROPYLPARABEN (UNII: Z8IX2SC1OH) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) NIACINAMIDE (UNII: 25X51I8RD4) PANTHENOL (UNII: WV9CM0O67Z) METHYLPARABEN (UNII: A2I8C7HI9T) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) SODIUM CHLORIDE (UNII: 451W47IQ8X) MAGNESIUM OLETH SULFATE (UNII: LCQ4WP3DTL) LINALOOL, (+/-)- (UNII: D81QY6I88E) WATER (UNII: 059QF0KO0R) SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) PEG-3 DISTEARATE (UNII: 8420ECX438) SODIUM BENZOATE (UNII: OJ245FE5EU) DMDM HYDANTOIN (UNII: BYR0546TOW) PEPPERMINT OIL (UNII: AV092KU4JH) MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) BENZYL ALCOHOL (UNII: LKG8494WBH) GREEN TEA LEAF (UNII: W2ZU1RY8B0) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82157-003-20 200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M032 12/01/2022 Labeler - Wella Operations US LLC (117781338)
