THICKER FULLER HAIR - DANDRUFF SULFATE FREE- salicylic acid shampoo

Thicker Fuller Hair - Dandruff Sulfate Free by

Drug Labeling and Warnings

Thicker Fuller Hair - Dandruff Sulfate Free by is a Otc medication manufactured, distributed, or labeled by Golden Sun DBA Newhall Laboratories, COSMETIC LABORATORIES OF AMERICA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

THICKER FULLER HAIR - DANDRUFF SULFATE FREE 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31774-1018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	18 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31774-1018-1	355 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358F	12/16/2013

Labeler - Golden Sun DBA Newhall Laboratories (060383791)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC LABORATORIES OF AMERICA		013696501	MANUFACTURE(31774-1018)