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NDC 49035-0437-14 Equate Beauty Color Safe Dandruff 10 mg/mL Details

Equate Beauty Color Safe Dandruff 10 mg/mL

Equate Beauty Color Safe Dandruff is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Store Inc. The primary component is PYRITHIONE ZINC.

Product Information

NDC	49035-0437
Product ID	49035-437_31bafec2-a105-4e41-8e53-9913642a8a77
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 Beauty Color Safe 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 Store 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 49035-0437-14 (49035043714)

Pricing Information	N/A
NDC Package Code	49035-437-14
Billing NDC	49035043714
Package	420 mL in 1 BOTTLE, PLASTIC (49035-437-14)
Marketing Start Date	2016-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eb5a9cc6-278c-4545-84ad-daa38199b615 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 maximum dandruff control, use every time you shampoo.
wet hair, massage onto scalp and rinse.
repeat if desired.

Inactive ingredients

Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Glycol Distearate, Cocamide MEA, Sodium Xylenesulfonate, Cetyl Alcohol, Dimethicone, Prunus Amygdalus (Sweet Almond) Fruit Extract, Fragrance (Parfum), Silicone Quaternium-22, Guar Hydroxypropyltrimonium Chloride, Amodimethicone, Laureth-9, Glycerin, Trideceth-12, Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone.

Questions or comments?

1-888-287-1915

Label Copy

INGREDIENTS AND APPEARANCE

EQUATE BEAUTY COLOR SAFE DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-437
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)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALMOND OIL (UNII: 66YXD4DKO9)
QUATERNIUM-22 (UNII: MXO138JCBP)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
AMODIMETHICONE (3500 CST) (UNII: 42AFE8JAOY)
POLIDOCANOL (UNII: 0AWH8BFG9A)
GLYCERIN (UNII: PDC6A3C0OX)
TRIDECETH-12 (UNII: YFY3KG5Y7O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-437-14	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/15/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/15/2016

Labeler - Wal-Mart Store Inc (051957769)

Registrant - Apollo Health and Beauty Care (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care		201901209	manufacture(49035-437)

Revised: 12/2016

Document Id: 31bafec2-a105-4e41-8e53-9913642a8a77

Set id: eb5a9cc6-278c-4545-84ad-daa38199b615

Version: 1

Effective Time: 20161219