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NDC 49035-0254-01 Equate Everyday Clean Dandruff 10 mg/mL Details

Equate Everyday Clean Dandruff 10 mg/mL

Equate Everyday Clean Dandruff is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. The primary component is PYRITHIONE ZINC.

Product Information

NDC	49035-0254
Product ID	49035-254_cb981326-9ecd-445a-827f-754132339448
Associated GPIs	46300010000330
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	Equate Everyday Clean Dandruff
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	Wal-Mart Stores, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2023-12-31

Package

Package Images

NDC 49035-0254-01 (49035025401)

Pricing Information	N/A
NDC Package Code	49035-254-01
Billing NDC	49035025401
Package	420 mL in 1 BOTTLE, PLASTIC (49035-254-01)
Marketing Start Date	2019-01-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4c84a67a-1f43-4f40-a172-271de7e76785 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 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?

1-888-287-1915

SPL UNCLASSIFIED SECTION

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label

NDC 49035-254-01

equate™

Compare

to Head &

Shoulders®

Active

Ingredient*

Everyday

Clean

Dandruff Shampoo

With Pyrithione Zinc

Basic everyday cleaning
Leaves hair feeling soft

and manageable

14.2 FL OZ (420 mL)

05-3710A

PRINCIPAL DISPLAY PANEL - 420 mL Bottle Label

INGREDIENTS AND APPEARANCE

EQUATE EVERYDAY CLEAN DANDRUFF ANTI-DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-254
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:49035-254-01	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	01/31/2019

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Garcoa, Inc.		036464697	MANUFACTURE(49035-254)

Revised: 1/2022

Document Id: cb981326-9ecd-445a-827f-754132339448

Set id: 4c84a67a-1f43-4f40-a172-271de7e76785

Version: 2

Effective Time: 20220106

Search by Drug Name or NDC

NDC 49035-0254-01 Equate Everyday Clean Dandruff 10 mg/mL Details

Equate Everyday Clean Dandruff 10 mg/mL

Product Information

Package

Package Images

NDC 49035-0254-01 (49035025401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4c84a67a-1f43-4f40-a172-271de7e76785 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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