DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

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

Drug Details [pdf]

Claims

Dandruff  Care for Great Looking Hair

Helps relieve scalp dryness, itch, irritation and helps prevent flakes

Active Ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

help 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 ingredient section

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 zince Dandruff Shampoo + Conditioner

Adverse Reaction

DISTRIBUTED BY

WAKEFERN FOOD CORP.

5000 RIVERSIDE DRIVE

KEASBEY, NJ 08832

1-800-SHOPRITE

CONTACT US:

www.shoprite.com

311.007/311AK-AM

principal display panel

Compare to Head & Shoulders

ShopRite

2 in 1

Dandruff

Shampoo plus

Conditioner

Basic Cleaning for

Normal & Oily Hair

pyrithione zinc

dandruff shampoo &

conditioner

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-311
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: 41190-311-35	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/2009
2	NDC: 41190-311-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/4119

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	04/09/2009

Labeler - Wakefern (069722418)

Registrant - Vi Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon, Inc		790752542	manufacture(41190-311)