DANDRUFF- pyrithione zinc lotion/shampoo

Dandruff by

Drug Labeling and Warnings

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

Drug Details [pdf]

claims

Healthy

Accents

everyday clean

dandruff shampoo

plus conditioner

2 in 1 pyrithione zinc    

Active ingredient

Pyrithione zinc

Purpose

Anti-dandruff

Use

helps prevent recurence 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 controll, 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, zince carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, quar 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 Zinc Dandruff Shampoo & Conditioner.

Adverse Reactions

DISTRIBUTED BY: DZA BRANDS, LLC

2110  Executive Drive, Salisbury, NC 28147

1-855-322-2439

principal display panel

healthy

accents

everyday clean

dandruff

shampoo

plus conditioner

2 in 1

pyrithione zinc

dandruff care that cleans

& conditions normal hair

compare to the active ingredient

of Head & Shoulders

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF  
pyrithione zinc lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 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)
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: 55316-311-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/02/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/02/2005

Labeler - DZA Brands LLC (090322194)

Registrant - Vi Jon Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon Inc		790752542	manufacture(55316-311)