DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

Dandruff by is a Otc medication manufactured, distributed, or labeled by Walgreen Co, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Claims

MULTIPLE BENEFIT FORMULA TO HELP:

• Fight dry scalp
• Calm itch
• Relieve irritation
• Soothe and reduce redness
• Reduce oilness
• Prevent flakes
• Leave hair healthy looking

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, sodim benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

Adverse reactions

Walgreens Pharmacist Survey Study, November 2014.

This product is not manufactured or distributed by

Procter & Gamble, distributor of Head & Shoulders

dandruff shampoo + conditioner Old Spice Men 2 in 1

Adverse Reaction

DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED  walgreens. com 2016 Walgreen Co

253.001/253AD

principal display panel

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED

MEN'S

2-IN-1

Dandruff

Shampoo & 

Conditioner

Pyrithione Zinc 1%

• Helps relieve scalp dryness, itch & irritation
• Helps prevent flakes
• Dual formula cleans & conditions hair in one easy step
• Gentle

NAUTICAL SPICE

13.5 fl oz

(399 mL)

Compare to Head & Shoulders Old Spice Men 2 in 1

INGREDIENTS AND APPEARANCE

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0253
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: 0363-0253-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016
2	NDC: 0363-0253-92	399 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/31/2016

Labeler - Walgreen Co (008965063)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(0363-0253)