pyrithione zinc by Vi-Jon, Inc PYRITHIONE ZINC shampoo

pyrithione zinc by

Drug Labeling and Warnings

pyrithione zinc by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

LET'S BE HONEST, THAT SHAMPOO YOU'RE USING NOW-IT DOESN'T REALLY SUIT YOU, BE A LEGEND

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

• do not get into eyes.  If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

• condition worsens or does not improve after regular use as directed

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• shake well before use
• for maximum dandruff control, use every time you shampoo
• wet hair, massage onto scalp, rinse, repeat if desired
• for best results use at least twice a week or as directed by a doctor

Inactive ingredients

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylisothiazolinone, methylchloroisothiazolinone, citric acid, sodium hydroxide, blue 1, green 3

SPL UNCLASSIFIED SECTION

Distributed by: Vi-Jon, Inc.

8515 Page Ave, St. Louis, MO 63114

928.000/928.AA

principal display panel

NEW

VICTORY DANDRUFF SHAMPOO +CONDITIONER

PYRITHIONE ZINC

A POWERFUL TWIST ON THE STANDARD HELPS RELIEVE SCALP DRYNESS ITCH, FLAKES & IRRITATION

2-in-1

LEGENDARY

FOR MEN

14.2 FL OZ ( 420 mL)

INGREDIENTS AND APPEARANCE

PYRITHIONE ZINC 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-928
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
pyrithione zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	pyrithione zinc	10.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-928-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/17/2016

Labeler - Vi-Jon, Inc (150931459)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		150931459	manufacture(11344-928)