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NDC 49035-0440-14 Equate beauty Color Safe Dandruff Conditioner 3 mg/mL Details

Equate beauty Color Safe Dandruff Conditioner 3 mg/mL

Equate beauty Color Safe Dandruff Conditioner is a TOPICAL LIQUID 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	49035-0440
Product ID	49035-440_53cb48b3-fe37-4096-9a05-103b646cd5d1
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 Conditioner
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pyrithione Zinc
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	3
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 49035-0440-14 (49035044014)

Pricing Information	N/A
NDC Package Code	49035-440-14
Billing NDC	49035044014
Package	420 mL in 1 BOTTLE, PLASTIC (49035-440-14)
Marketing Start Date	2016-12-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 22a21cbd-78da-4fa8-a466-447d033b9077 Details

Active ingredient

Pyrithione Zinc 0.3%

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 after shampooing with Color Safe Dandruff Shampoo.
apply conditioner generously to hair, working through ends. Wait 3-5 minutes.
rinse hair thoroughly.

Inactive ingredients

Water (Aqua), Stearyl Alcohol, Behentrimonium Chloride, Cetyl Alcohol, Dimethicone, Cocos Nucifera (Coconut) Oil, PPG-3 Benzyl Ether Ethylhexanoate, Fragrance (Parfum), Lauryl PEG/PPG-18/18 Methicone, Hydroxyethylcellulose, Sodium Hydroxide, Methylchloroisothiazolinone, Methylisothiazolinone.

Questions or comments?

1-888-287-1915

Label Copy

INGREDIENTS AND APPEARANCE

EQUATE BEAUTY COLOR SAFE DANDRUFF CONDITIONER

pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-440
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCONUT OIL (UNII: Q9L0O73W7L)
PPG-3 BENZYL ETHER ETHYLHEXANOATE (UNII: 3N703GY99W)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-440-14	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(49035-440)

Revised: 12/2016

Document Id: 53cb48b3-fe37-4096-9a05-103b646cd5d1

Set id: 22a21cbd-78da-4fa8-a466-447d033b9077

Version: 1

Effective Time: 20161219