DANDRUFF- pyrithione zinc lotion/shampoo

Dandruff by

Drug Labeling and Warnings

Dandruff by is a Otc medication manufactured, distributed, or labeled by Demoulas Super Markets, Inc, Vi Jon, Inc. 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

• Keeps hair clean and manageable
• Gentle and pH balanced for every day use - even for permed and color-treated hair

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

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 Reactions

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET

TEWKSBURY, MA 01876

MADE IN USE WITH US AND FOREIGN COMPONENTS

311.007/311AK

principal display panel

MORE FOR YOUR DOLLAR

Market Basket

pyrithione zinc

Dandruff

Shampoo

plus conditioner everyday clean

For normal/Oily Hair

Compare to Head & Shoulders Active Ingredient

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF  
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	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: 53942-311-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/30/2009

Labeler - Demoulas Super Markets, Inc (007869647)

Registrant - Vi Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon, Inc		790752542	manufacture(53942-311)