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NDC 42507-0281-15 Dry Scalp Dandruff 10 mg/mL Details

Dry Scalp Dandruff 10 mg/mL

Dry Scalp Dandruff is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Hy-Vee, Inc. The primary component is PYRITHIONE ZINC.

Product Information

NDC	42507-0281
Product ID	42507-281_345922e0-5caf-46e4-a0a5-38b4750888fe
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Dry Scalp Dandruff
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pyrithione Zinc
Product Type	HUMAN OTC DRUG
Dosage Form	SHAMPOO
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	PYRITHIONE ZINC
Labeler Name	Hy-Vee, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2024-12-31

Package

Package Images

NDC 42507-0281-15 (42507028115)

Pricing Information	N/A
NDC Package Code	42507-281-15
Billing NDC	42507028115
Package	420 mL in 1 BOTTLE, PLASTIC (42507-281-15)
Marketing Start Date	2002-07-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 34135962-d5a9-40f7-a993-78faf21ca737 Details

claims

Dandruff Care for Great Looking Hair

This product helps relieve scalp dyrness, itch, irration and helps prevent flakes.

Dry Scalp Care and Shiny Clean Hair

with moisturizers, it soothes the scalp while cleaning and conditioning the hair
pH balanced for everyday use-even for permed or color-treated hair

active ingredient

Pyrithione 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, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Dry Scalp Care

adverse reactions

DISTRIBUTED BY HY-VEE, INC

WEST DES MOINES, IA 50266

SATISFACTION GUARANTEED

FOR INFORMATION CALL

1-800-289-8343 www.hy-vee.com

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient

in Head & Shoulders shampoo

Le TECHNIQ

hair

dry scalp

dandruff

shampoo

with pyrithione zinc

moisturizers to relieve

dry scalp and itch

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DRY SCALP DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-281
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 (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)
ALMOND OIL (UNII: 66YXD4DKO9)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42507-281-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/19/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	07/19/2002

Labeler - Hy-Vee, Inc (006925671)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(42507-281)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(42507-281)

Revised: 6/2022

Document Id: 345922e0-5caf-46e4-a0a5-38b4750888fe

Set id: 34135962-d5a9-40f7-a993-78faf21ca737

Version: 15

Effective Time: 20220603