DANDRUFF- pyrithione zinc lotion/shampoo
Wakefern Food Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Claims

2 in 1 Dandruff Care For Great Looking Hair

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

Active ingredients

Active ingrediet

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

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

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

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 reactions

Distributed by

Wakefern Food Corp

5000 Riverside Drive

Keasbey, NJ 08832

1-800-shoprite

www.shoprite.com

Principal display panel

COMPARE TO ACTIVE INGREDIENT

IN HEAD + SHOULDERS

ShopRite

Dandruff

2 in1

Pyrithione Zinc

SHAMPOO PLUS

CONDITIONER

NORMAL

for normal hair

14.2 FL OZ

(420 mL)

image description

DANDRUFF
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:41190-311
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (PYRITHIONE ZINC)	PYRITHIONE ZINC	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
SODIUM LAURETH SULFATE
SODIUM LAURYL SULFATE
COCO MONOETHANOLAMIDE
ZINC CARBONATE
GLYCOL DISTEARATE
AMODIMETHICONE (800 CST)
CETYL ALCOHOL
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
MAGNESIUM SULFATE
SODIUM BENZOATE
MAGNESIUM CARBONATE HYDROXIDE
AMMONIUM LAURETH-3 SULFATE
BENZYL ALCOHOL
SODIUM CHLORIDE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
SODIUM XYLENESULFONATE
TRIDECETH-12
CETRIMONIUM CHLORIDE
SODIUM HYDROXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 4

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-311-15	.42 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	01/16/2009

Labeler - Wakefern Food Corp (069722418)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		088520668	manufacture(41190-311)

Revised: 8/2012

Document Id: 6cb086ff-0b83-4870-971f-198138a308c9

Set id: 260f521e-0998-47bd-9194-d636cdabf641

Version: 2

Effective Time: 20120831

Wakefern Food Corp