DRY SCALP CARE- pyrithione zinc shampoo
OnPoint, 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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Americas Choice 296.007 296AT AV

Claims

America's Choice

2 in 1

shampoo

DRY SCALP 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 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, sodim xylenesultonate, amodimethicone, cocamidopropyl betaine, fragrance. sodium benzoate, quar hydroxypropyltrimonium chloride, magnesum carbonate hydroxide, citric acid, prunus amydgalus dulcis (sweet almond) oil, methylchloroisothiazloinone, methylisothiazolinone

Disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Heard & Shoulders dry scalp care dandruff shampoo & conditioner.

adverse reactions section

DISTRIBUTED BY ONPOINT, INC.

2 PARAGON DRIVE

MONTVALE, NJ 07645

296.007/296AT

principal display panel

America's Choice

2 in 1

shampoo

DRY SCALP

DANDRUFF

PYRITHIONE ZINC

ANTI-DANDRUFF SHAMPOO

PLUS CONDITIONER

Compare to the active ingredient in Head & Shoulders dry scalp care dandruff shampoo & conditioner

WITH CONDITIONER

23.7 FL OZ (700 mL)

image description

DRY SCALP CARE
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51143-296
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)
ALMOND OIL (UNII: 66YXD4DKO9)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
methylisothiazolinone (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51143-296-35	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/04/1998	06/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	03/04/1998	06/11/2020

Labeler - OnPoint, Inc (001367366)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(51143-296)

Revised: 6/2020

Document Id: 45a37fa9-264f-4bdb-b28e-cfd3d14145e4

Set id: cb4d700b-8045-40ba-9017-eea25a7c5a1e

Version: 8

Effective Time: 20200611

OnPoint, Inc