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NDC 49035-0087-14 Equate Everyday Clean Gentle Dandruff 10 mg/mL Details

Equate Everyday Clean Gentle Dandruff 10 mg/mL

Equate Everyday Clean Gentle 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	49035-0087
Product ID	49035-087_0c6dd288-237c-45b3-bc73-59740ef29960
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 Gentle 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	Wal-Mart Stores, 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 49035-0087-14 (49035008714)

Pricing Information	N/A
NDC Package Code	49035-087-14
Billing NDC	49035008714
Package	420 mL in 1 BOTTLE, PLASTIC (49035-087-14)
Marketing Start Date	2018-02-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d93bee03-8abd-42e8-838e-1d25b7c3ed31 Details

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Uses

to help 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.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

For best results, use at least twice a week or as directed by a doctor.
wet hair, massage onto scalp and rinse.
repeat if desired.

Inactive ingredient

Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Laureth-4, Sodium Hydroxide, Polyquaternium-113, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (CI 17200), Blue 1 (CI 42090)

Questions or comments?

1-888-287-1915

Label copy

INGREDIENTS AND APPEARANCE

EQUATE EVERYDAY CLEAN GENTLE DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-087
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 SULFATE (UNII: BPV390UAP0)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-087-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/08/2018
2	NDC:49035-087-14	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/08/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	02/08/2018

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

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(49035-087)

Revised: 2/2018

Document Id: 0c6dd288-237c-45b3-bc73-59740ef29960

Set id: d93bee03-8abd-42e8-838e-1d25b7c3ed31

Version: 1

Effective Time: 20180209