DANDRUFF- pyrithione zinc shampoo
Wakefern

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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Shop Rite 311.007 311AM

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

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)

image description

DANDRUFF
pyrithione zinc shampoo

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-311-35	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/2009	09/11/2020
2	NDC:41190-311-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/09/2009	09/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	04/09/2009	09/11/2020

Labeler - Wakefern (069722418)

Registrant - Vi Jon, Inc (790752542)

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

Revised: 9/2020

Document Id: d1f652e2-4eab-4d0a-a686-4b1fa26b132f

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

Version: 10

Effective Time: 20200911

Wakefern