VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]

VITALE SENSITIVE SCALP DAILY SCALP HEALER (PYRITHIONE ZINC) CREAM [JF LABS, INC.]
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NDC 49681-001-01
Set ID 9aeada50-2cb2-d113-126a-ddcf05f817b6
Category HUMAN OTC DRUG LABEL
Packager New Life Products, Inc.
Generic Name
Product Class
Product Number
Application Number PART358
  • Drug Facts

  • Active Ingredient

    Pyrithione Zinc 0.25%

  • Purpose

    Anti-Dandruff

  • Use

    Controls the symptoms of dandruff

  • Warnings

    For external use only

    Ask a doctor before use if you have a condition that covers a large area of the body.

    When using this product avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

    Stop use and ask adoctor if condition worsens or dowes 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:

    For best results apply to affected areas one to four times daily or as directed by a doctor. Spread a small amount in the palms of your hands and apply evenly to the scalp and entire head of hair. Style as desired.

  • Inactive ingredients

    Water (Aqua), Glycerin, Propylene Glycol, Mineral Oil (Paraffinum Liquidum), Lanolin, Acetamide MEA, Cetyl Alcohol, Cetearyl Alcohol, Polysorbate 60, Beeswax, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Menthol, Camphor, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Juice, Dimethicone, Tocopherol Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Stearalkonium Chloride, Polyquaternium-11, Biotin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Equisetum Arvense Extract, Humulus Lupulus (Hops) Extract, Citrus Medica Limonum, (Lemon) Peel Extract, Sodium Borate, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance, (Parfum)

  • SPL UNCLASSIFIED SECTION

    AFAM CONCEPT, INC.
    Chicago, IL 60629

    London NW 10 6JH
    UK

    (800) 262-2326
    (773) 838-1336

    Registered # 1,387,930

  • Packaging

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    VITALE SENSITIVE SCALP DAILY SCALP HEALER 
    pyrithione zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC250 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ACETIC MONOETHANOLAMIDE (UNII: A9O0818TWD)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    BIOTIN (UNII: 6SO6U10H04)  
    ROSEMARY (UNII: IJ67X351P9)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    HOPS (UNII: 01G73H6H83)  
    LEMON PEEL (UNII: 72O054U628)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite (Off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49681-001-01114 g in 1 JAR; Type 0: Not a Combination Product11/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/01/2009
    Labeler - New Life Products, Inc. (117815140)
    Registrant - New Life Products, Inc. (117815140)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Life Products, Inc.117815140manufacture(49681-001)

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