DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

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

Drug Details [pdf]

Optional Claims

Multiple benefit formula to help:

• Fight dry scalp
• Calm itch
• Relieve iritation
• Soothe and reduce redness
• Reduce oilness
• Prevent flakes
• Leave hair healthy looking

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
• 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, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

Dislcaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Classic Clean pyrithione zinc Dandruff Shampoo

Adverse Reaction

Manufactured by: Vi-Jon, Inc.,

St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

Made in the USA

with US and foreign parts

153.008/153AZ Rev 1

principal display panel

mountain

falls

Compare to Head & Shoulders

helps prevent flakes

leaves hair clean and manageable

helps relieve scalp dryness, itch and irritation

pH balanced formula

dandruff shampoo

with pyrithione zinc

everyday clean

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0153
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 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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0153-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/13/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/13/2009

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(0869-0153)