THICKER FULLER HAIR - DANDRUFF SULFATE FREE- salicylic acid shampoo 
Golden Sun DBA Newhall Laboratories

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.

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Thicker Fuller Hair® - Dandruff Sulfate Free

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

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
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)

Revised: 12/2013
Document Id: fd6f35a4-5c60-4791-8138-ad6f851597ff
Set id: 25840d10-e8c6-4a1a-b014-26c25211483b
Version: 1
Effective Time: 20131202
 
Golden Sun DBA Newhall Laboratories