Label: THICKER FULLER HAIR - DANDRUFF SULFATE FREE- salicylic acid shampoo

  • 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, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 1.8%

  • Purpose

    Anti-Dandruff

  • Use

    Controls flaking associated with dandruff

  • Warnings

    For external use only

    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • If condition worsens or does not improve after regular use of this product as directed, consult a doctor.

    • Keep out of reach of children.
  • Directions

    Wet hair, lather and rinse thoroughly. For best results, use at least twice a week or as directed by a doctor.

  • Inactive Ingredients

    WATER (AQUA, EAU), SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, PEG-4 RAPESEEDAMIDE PANTHENOL, ALOE BARBADENSIS LEAF JUICE, THYMUS VULGARIS (THYME) EXTRACT, SALVIA SCLAREA (CLARY) EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, KRAMERIA TRIANDRA ROOT EXTRACT, EUCALYPTUS GLOBULUS LEAF EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, HYDROLYZED VEGETABLE PROTEIN PG-PROPYL SILANETRIOL, SODIUM PCA, CAFFEINE, GLYCERIN, PEG-150 DISTEARATE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, TRIMETHYLSILOXYAMODIMETHICONE, POLYSORBATE 20, C11-15 PARETH-7, TRIDECETH-12, C12-16 PARETH-9, HYDROLYZED QUINOA, SODIUM HYDROXIDE, SODIUM CHLORIDE, BUTYLENE GLYCOL, CITRIC ACID, PEG/PPG-18/18 DIMETHICONE, DISODIUM EDTA, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, FRAGRANCE (PARFUM), BUTYLPHENYL METHYLPROPIONAL, HEXYL CINNAMAL, HYDROXYCITRONELLAL, LIMONENE, LINALOOL

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    Newhall Laboratories, Inc.
    5 High Ridge Park, Suite 100
    Stamford, CT 06905

  • PRINCIPAL DISPLAY PANEL - 355 ml Bottle Label

    New!

    THICKER
    FULLER
    HAIR    ®

    ADVANCED THICKENING SOLUTIONS

    DANDRUFF

    SULFATE
    FREE
    SHAMPOO

    CELL-U-PLEX
    PURE PLANT EXTRACTS
    WITH CAFFEINE ENERGIZERS

    THICKEN
    PURIFY
    REVIVE
    fine
    thin
    limp
    hair

    355 ml e 12 FL OZ

    Principal Display Panel - 355 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    THICKER FULLER HAIR - DANDRUFF SULFATE FREE 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31774-1018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid18 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    THYME (UNII: CW657OBU4N)  
    ROSEMARY (UNII: IJ67X351P9)  
    KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CAFFEINE (UNII: 3G6A5W338E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    C11-15 PARETH-7 (UNII: 261HPE0IS3)  
    TRIDECETH-12 (UNII: YFY3KG5Y7O)  
    C12-16 PARETH-9 (UNII: 9DJ758090Y)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31774-1018-1355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358F12/16/2013
    Labeler - Golden Sun DBA Newhall Laboratories (060383791)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMETIC LABORATORIES OF AMERICA013696501MANUFACTURE(31774-1018)
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