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NDC 70000-0533-01 Leader Dandruff Everyday Clean 10 mg/mL Details

Leader Dandruff Everyday Clean 10 mg/mL

Leader Dandruff Everyday Clean is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. The primary component is PYRITHIONE ZINC.

Product Information

NDC	70000-0533
Product ID	70000-0533_02098680-dc3a-44f9-9498-697f2d0cd16e
Associated GPIs	90300040004510
GCN Sequence Number	006175
GCN Sequence Number Description	pyrithione zinc SHAMPOO 1 % TOPICAL
HIC3	L5E
HIC3 Description	ANTISEBORRHEIC AGENTS
GCN	24170
HICL Sequence Number	013409
HICL Sequence Number Description	PYRITHIONE ZINC
Brand/Generic	Generic
Proprietary Name	Leader Dandruff Everyday Clean
Proprietary Name Suffix	Anti-Dandruff
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	Cardinal Health, 110 dba LEADER
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 70000-0533-01 (70000053301)

Pricing Information	N/A
NDC Package Code	70000-0533-1
Billing NDC	70000053301
Package	420 mL in 1 BOTTLE, PLASTIC (70000-0533-1)
Marketing Start Date	2019-10-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7757ca84-8282-4465-a467-cd3f127d1286 Details

SPL UNCLASSIFIED SECTION

Drug Facts

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 (1-800-222-1222) right away.

Directions

♦: shake well
♦: wet hair
♦: massage onto scalp
♦: rinse
♦: repeat if desired
♦: for best results use at least twice a week or as directed by a doctor
♦: for maximum dandruff control, use every time you shampoo

Other information

store at room temperature

Inactive ingredients

water, sodium laureth sulfate, cocamide MEA, sodium lauryl sulfate, glycol distearate, dimethicone, fragrance, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, citric acid, blue 1, red 4.

Questions or comments?

1-866-567-8600

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OH 43017

PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label

LEADER™

NDC 70000-0533-1

Dandruff

Shampoo

Pyrithione Zinc, 1%

Anti-Dandruff

Everyday

Clean

Basic Everyday

Cleaning for

Normal Hair

COMPARE TO

HEAD &

SHOULDERS®

active ingredient*

100% Money

Back Guarantee

14.2 FL OZ (420 mL)

05-3789

PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label

INGREDIENTS AND APPEARANCE

LEADER DANDRUFF EVERYDAY CLEAN ANTI-DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0533
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 Laureth-3 Sulfate (UNII: BPV390UAP0)
Coco Monoethanolamide (UNII: C80684146D)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Glycol Distearate (UNII: 13W7MDN21W)
Dimethicone (UNII: 92RU3N3Y1O)
Cetyl Alcohol (UNII: 936JST6JCN)
Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) (UNII: B16G315W7A)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Sodium Benzoate (UNII: OJ245FE5EU)
Magnesium Carbonate Hydroxide (UNII: YQO029V1L4)
Ammonium Laureth-5 Sulfate (UNII: 43ZIH89I48)
Benzyl Alcohol (UNII: LKG8494WBH)
Sodium Chloride (UNII: 451W47IQ8X)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
Sodium Xylenesulfonate (UNII: G4LZF950UR)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
Fd&C Red No. 4 (UNII: X3W0AM1JLX)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0533-1	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	10/10/2019

Labeler - Cardinal Health, 110 dba LEADER (063997360)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Sigan Industries INC.		255106239	MANUFACTURE(70000-0533)

Revised: 10/2022

Document Id: 02098680-dc3a-44f9-9498-697f2d0cd16e

Set id: 7757ca84-8282-4465-a467-cd3f127d1286

Version: 3

Effective Time: 20221012

Search by Drug Name or NDC

NDC 70000-0533-01 Leader Dandruff Everyday Clean 10 mg/mL Details

Leader Dandruff Everyday Clean 10 mg/mL

Product Information

Package

Package Images

NDC 70000-0533-01 (70000053301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7757ca84-8282-4465-a467-cd3f127d1286 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Use

Warnings

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label

INGREDIENTS AND APPEARANCE

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