Dandruff (Pyrithione Zinc) Shampoo [American Sales Company] -

DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AMERICAN SALES COMPANY]
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NDC	41520-309-15
Set ID	967c4164-df7c-48df-bdfe-43ec337857fa
Category	HUMAN OTC DRUG LABEL
Packager	American Sales Company
Generic Name
Product Class
Product Number
Application Number	PART358H

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claims
Dandruff Care for Great Looking Hair

This product helps relieves scalp dryness, itch, irritation and helps prevent flakes.

A Refreshing Sensation and Clean Manageable Hair
- Contains mint for a cool, refreshing sensation and leaves hair clean and manageable
- pH balanced for everyday use - even for permed or color-treated hair
Active ingredient

Pyritione zinc 1%

Purpose

Anti-dandruff
Use

helps prevent recurrence of flaking and itching associated with dandruff
warning
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, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33
adverse reaction

Distributed by: American Sales Company
4201 Walden Avenue, Lancaster, NY 14086
Quality guaranteed or your money back

309.009/309AR
principal display panel

CAREONE

refreshingly cool

Dandruff

shampoo

invigorates

pyrithione zinc

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-309
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g in 100 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 (1300 CST) (UNII: 3V7U636DWN)
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:41520-309-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/10/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	02/10/2011

Labeler - American Sales Company (809183973)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41520-309)

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Medic

DANDRUFF (PYRITHIONE ZINC) SHAMPOO [AMERICAN SALES COMPANY]

Purpose

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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