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NDC 42507-0424-14 Hyvee Care Classic Clean 2 in 1 Dandruff 10 mg/mL Details

Hyvee Care Classic Clean 2 in 1 Dandruff 10 mg/mL

Hyvee Care Classic Clean 2 in 1 Dandruff is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Hyvee Inc. The primary component is PYRITHIONE ZINC.

Product Information

NDC	42507-0424
Product ID	42507-424_a113e914-b7d4-43a0-bbef-4bf2a5a801c4
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	Hyvee Care Classic Clean 2 in 1 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	Hyvee Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2022-12-31

Package

Package Images

NDC 42507-0424-14 (42507042414)

Pricing Information	N/A
NDC Package Code	42507-424-14
Billing NDC	42507042414
Package	420 mL in 1 BOTTLE, PLASTIC (42507-424-14)
Marketing Start Date	2016-06-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2121d6dc-e094-4f8b-85d9-e1bcef09ee65 Details

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

When using this product

avoid contact with 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 of this product as directed.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

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 (Aqua), Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Glycol Distearate, Zinc Carbonate, Sodium Chloride, Sodium Xylenesulfonate, Dimethicone, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Questions?

Call 1-866-695-3030

Label Copy

INGREDIENTS AND APPEARANCE

HYVEE CARE CLASSIC CLEAN 2 IN 1 DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-424
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)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
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:42507-424-14	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/13/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	06/13/2016

Labeler - Hyvee Inc (006925671)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(42507-424)

Revised: 6/2016

Document Id: a113e914-b7d4-43a0-bbef-4bf2a5a801c4

Set id: 2121d6dc-e094-4f8b-85d9-e1bcef09ee65

Version: 1

Effective Time: 20160614