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NDC 49035-0249-01 Equate Dry Scalp 2 in 1 Dandruff 10 mg/mL Details

Equate Dry Scalp 2 in 1 Dandruff 10 mg/mL

Equate Dry Scalp 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	49035-0249
Product ID	49035-249_26ca504e-bc52-4289-bfb5-3e1ac2a4e1fe
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 Dry Scalp 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	2024-12-31

Package

Package Images

NDC 49035-0249-01 (49035024901)

Pricing Information	N/A
NDC Package Code	49035-249-01
Billing NDC	49035024901
Package	399 mL in 1 BOTTLE, PLASTIC (49035-249-01)
Marketing Start Date	2018-12-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6440fdd9-daa8-4f15-bdee-33724993bd7b 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, prunus amygdalus dulcis (sweet almond) oil, 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

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 49035-249-01

equate™

Compare

to Head &

Shoulders®

Active

Ingredient*

Dry

Scalp

2 in 1

Dandruff Shampoo

Plus Conditioner

With Pyrithione Zinc

With Almond Oil
Helps relieve dry, itchy scalp

associated with dandruff

13.5 FL OZ (399 mL)

05-3706

PRINCIPAL DISPLAY PANEL - 399 mL Bottle Label

INGREDIENTS AND APPEARANCE

EQUATE DRY SCALP 2 IN 1 DANDRUFF ANTI-DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-249
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)
ALMOND OIL (UNII: 66YXD4DKO9)
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)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-249-01	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(49035-249)

Revised: 1/2022

Document Id: 26ca504e-bc52-4289-bfb5-3e1ac2a4e1fe

Set id: 6440fdd9-daa8-4f15-bdee-33724993bd7b

Version: 2

Effective Time: 20220110

Search by Drug Name or NDC

NDC 49035-0249-01 Equate Dry Scalp 2 in 1 Dandruff 10 mg/mL Details

Equate Dry Scalp 2 in 1 Dandruff 10 mg/mL

Product Information

Package

Package Images

NDC 49035-0249-01 (49035024901)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6440fdd9-daa8-4f15-bdee-33724993bd7b 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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