DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

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

Drug Details [pdf]

Claims

Dandruff Care for Great Looking Hair

This product helps relieve scalp dryness, itch, irritation and helps prevent flakes.

Clean Manageable Hair Everyday

• Dual formula cleans and conditions hair in one easy step
• Gentle and pH balanced for everyday use-even for permed or color-treated hair

Active ingredients

Active ingredient

Pyrithione zinc 1%

Purpose

Purpose

Anti-dandruff

Use

Use helps prevent recurrence of flaking and itching associated with dandruff

Warnings

Warnings

For external use only

When using this product

When using this product

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

Stop Use

Stop use and ask a doctor if

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

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Directions

• shake well
• 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

Inactive ingredientswater, sodium laureth sulfate, sodium lauryl sulfate, cocamideMEA, zinc carbonate, glycol distearate, amodimethicone, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, trideceth-12, cetrimonium chloride, sodium hydroxide, yellow 10, blue 1, red 4

Disclaimer

This product is not manufactured or distributed by Procter + Gamble, the distributor of Head + Shoulders Classic Clean 2 in 1 pyrithione zinc Dandruff shampoo + conditioner

Adverse reaction

Distributed by: Hy-Vee, Inc.

West Des Moines, IA 50266

Satisfaction guaranteed For information call

1-800-289-8343 www.hy-vee.com

Principal display panel

Compare to the active ingredient

in Head + Shoulders shampoo

LE TECHNIQ hair

everyday clean

dandruff

shampoo

plus conditioner

with pyrithione zinc

2 in 1

for normal or oily hair

14.2 FL OZ (420 mL)

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
CETYL ALCOHOL (UNII: 936JST6JCN)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM SULFATE (UNII: DE08037SAB)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
TRIDECETH-12 (UNII: YFY3KG5Y7O)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-311-15	0.420 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/16/2006

Labeler - Hy-Vee Inc (006925671)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(42507-311)