EVERYDAY CLEAN DANDRUFF- pyrithione zinc shampoo
On-Point, Inc

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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America's Choice 153

Claims

America's Choice

Shampoo

EVERYDAY CLEAN DANDRUFF

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 occures, 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 hydroxupropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, methylchloroisothiazolinone, methylisothiazonlinone, blue 1, red 33

disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Classic Clean pyrithione zinc dandruff shampoo

Adverse reactions

DISTRIBUTED BY ONPOINT, INC.

2 PARAGON DRIVE

MONTVALE, NJ 07645

153.008/153AZ Rev 1

principal display panel

shampoo

EVERYDAY

CLEAN

DANDRUFF

PYRITHIONE ZIC

ANTI-DANDRUFF SHAMPOO

Compare to the active ingredient in Heads & Shoulders classic clean dandrff shampoo

FOR NORMAL / OILY HAIR

23.7 FL OZ (700 mL)

image description

EVERYDAY CLEAN DANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51143-153
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:51143-153-35	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/1995	07/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	02/15/1995	07/31/2020

Labeler - On-Point, Inc (001367366)

Registrant - Vi-Jon, Inc (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc		790752542	manufacture(51143-153)

Revised: 7/2020

Document Id: de165a08-8742-4670-954d-20b8295f40b5

Set id: b9c810ed-b987-4561-ad28-9bbe66cc23d2

Version: 6

Effective Time: 20200731

On-Point, Inc