GKHAIR ANTI-DANDRUFF- pyrithione zinc shampoo
Van Tibolli Beauty Corp.

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.

----------

GKhair Anti-Dandruff Shampoo

DRUG FACTS

Active Ingredient: Pyrithione Zinc 1%

Purpose: Anti-dandruff

Use

Helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

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

Stop use and ask a doctor if condition worsens or does 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 maximum dandruff control, use every time you shampoo.
Wet hair, massage unto scalp, rinse, and repeat if desired.
For best results use at least twice a week or as directed by a doctor.

Questions or Comments?

Call 1.888.JUVEXIN (888-588-3946)/ 305-390-0044

Inactive Ingredients

Aqua, Sodium C14-16 Olefin Sulfonate, Acrylates Copolymer, Cocamidopropyl Betaine, Cocamide MEA, Cocamidopropylamine Oxide, Caprylyl Glycol, Sodium Hydroxide, Polyquaternium-7, Fragrance, Panthenol, Disodium EDTA, Citric Acid, Methylisothiazolinone, Benzyl Salycilate, Coumarin, Eugenol, Gamma Methyl Ionone, Geraniol, Hexyl Cinnamic Aldehyde, Linalool, FD&C Blue #1.

GKhair, Hair Taming System, and Juvexin are trademarks of Van Tibolli Beauty S.a.r.l.

www.GKhair.com +1.305.390.0044

VAN TIBOLLI CORP. Fort Lauderdale, FL

Made in USA./ Hecho en EE.UU.

Van Tibolli Ltd.

Garryard House Floor 4, Earlsfort Terrace, Dublin 2, Ireland

GKHAIR ANTI-DANDRUFF SHAMPOO

NDC 62868-221-25

PRO LINE

HAIR TAMING SYSTEM WITH JUVEXIN

250 ml e 8.5 fl. oz.

image description

GKHAIR ANTI-DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:62868-221
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (PYRITHIONE ZINC)	PYRITHIONE ZINC	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
SODIUM C14-16 OLEFIN SULFONATE
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)
COCAMIDOPROPYL BETAINE
COCO MONOETHANOLAMIDE
COCAMIDOPROPYLAMINE OXIDE
CAPRYLYL GLYCOL
SODIUM HYDROXIDE
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)
PANTHENOL
EDETATE DISODIUM
CITRIC ACID MONOHYDRATE
METHYLISOTHIAZOLINONE
BENZYL SALICYLATE
COUMARIN
EUGENOL
ISOMETHYL-.ALPHA.-IONONE
GERANIOL
.ALPHA.-HEXYLCINNAMALDEHYDE
LINALOOL, (+/-)-
FD&C BLUE NO. 1

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62868-221-25	250 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	04/09/2014

Labeler - Van Tibolli Beauty Corp. (844931951)

Revised: 4/2014

Document Id: 4d61348d-ae5c-46c3-8654-0e17dad8967e

Set id: 08312224-70e9-4ee5-b075-8a5d77dd137d

Version: 1

Effective Time: 20140409

Van Tibolli Beauty Corp.