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NDC 49035-0680-01 Equate Everyday Clean 2 in 1 Dandruff 10 mg/mL Details

Equate Everyday Clean 2 in 1 Dandruff 10 mg/mL

Equate Everyday Clean 2 in 1 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	49035-0680
Product ID	49035-680_96dd16dd-9960-4378-9ece-5de121deed0c
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	Equate Everyday Clean 2 in 1 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 49035-0680-01 (49035068001)

Pricing Information	N/A
NDC Package Code	49035-680-01
Billing NDC	49035068001
Package	399 mL in 1 BOTTLE, PLASTIC (49035-680-01)
Marketing Start Date	2018-12-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c85095f2-5dbd-4822-a83a-dc3641c4a330 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

♦: avoid contact with the 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 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, polyquaternium-10, 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

SPL UNCLASSIFIED SECTION

Satisfaction guaranteed – For questions or comments please call 1-888-287-1915.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

PRINCIPAL DISPLAY PANEL - 399 mL Bottle Label

NDC 49035-680-01

equate™

Compare

to Head &

Shoulders®

Active

Ingredient*

Everyday

Clean

2 in 1

Dandruff Shampoo &

Conditioner

With Pyrithione Zinc

Basic everyday cleaning

and conditioning
Leaves hair feeling soft

and manageable

13.5 FL OZ (399 mL)

05-3702

PRINCIPAL DISPLAY PANEL - 399 mL Bottle Label

INGREDIENTS AND APPEARANCE

EQUATE EVERYDAY CLEAN 2 IN 1 DANDRUFF ANTI-DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-680
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)
Polyquaternium-10 (30000 MPA.S at 2%) (UNII: C7RDC8Y4JS)
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:49035-680-01	399 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	12/17/2018

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

Registrant - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Garcoa, Inc.		036464697	MANUFACTURE(49035-680)

Revised: 1/2022

Document Id: 96dd16dd-9960-4378-9ece-5de121deed0c

Set id: c85095f2-5dbd-4822-a83a-dc3641c4a330

Version: 2

Effective Time: 20220106

Search by Drug Name or NDC

NDC 49035-0680-01 Equate Everyday Clean 2 in 1 Dandruff 10 mg/mL Details

Equate Everyday Clean 2 in 1 Dandruff 10 mg/mL

Product Information

Package

Package Images

NDC 49035-0680-01 (49035068001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c85095f2-5dbd-4822-a83a-dc3641c4a330 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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 399 mL Bottle Label

INGREDIENTS AND APPEARANCE

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