DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Dandruff Care for Great Looking Hair
Helps relieve scalp dryness, itch, irritation and helps prevent flakes

Active ingredient

Pyritione 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 ue 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
• gently massage into your scalp and work through to the tips of your hair
• for best results use at least twice a week or as directed by a doctor

Inactive ingredients

water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, amodimethicone, sodium xylenesulfonate, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide, benzyl alcohol, tocopheryl acetate, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, yellow 5, blue 1

Disclaimer

This product is not manufactured or distributed by Procter + Gamble, the distributor of Head + Shoulders 2 in 1 Hair Enducance for Men

Adverse Reactions

Distributed By:

Wakefern Food Corp.

5000 Riverside Drice

Keasbey, NJ 08832

Call: 1-800-SHOPRITE

Email: www.shoprite.com

Principal Display Panel

COMPARE TO head + shoulders

Shop Rite

MEN's 2 in 1

Dandruff

Shampoo

+ conditioner

Pyrithione Zinc

HYDRATING TO RELIEVE DRY SCALP + ITCH

Designed to leave hair feeling soft and looking full

Leaves hair feeling moisturized, touchable and vibrant

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF  
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-931
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
CETYL ALCOHOL (UNII: 936JST6JCN)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM SULFATE (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41190-931-15	420 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/15/1998

Labeler - Wakefern Food Corp (069722418)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(41190-931)