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NDC 62839-6745-01 Epoch Ava Puhi Moni Anti-Dandruff 65.7 g/1000mL Details

Epoch Ava Puhi Moni Anti-Dandruff 65.7 g/1000mL

Epoch Ava Puhi Moni Anti-Dandruff is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by NSE Products, Inc.. The primary component is PYRITHIONE ZINC.

Product Information

NDC	62839-6745
Product ID	62839-6745_faf5eb3a-7c3e-4a6c-b5c9-887883d341f5
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	Epoch Ava Puhi Moni Anti-Dandruff
Proprietary Name Suffix	n/a
Non-Proprietary Name	PYRITHIONE ZINC
Product Type	HUMAN OTC DRUG
Dosage Form	SHAMPOO
Route	TOPICAL
Active Ingredient Strength	65.7
Active Ingredient Units	g/1000mL
Substance Name	PYRITHIONE ZINC
Labeler Name	NSE Products, 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 62839-6745-01 (62839674501)

Pricing Information	N/A
NDC Package Code	62839-6745-1
Billing NDC	62839674501
Package	250 mL in 1 BOTTLE, PLASTIC (62839-6745-1)
Marketing Start Date	2017-02-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a91a736a-f044-43e7-85f2-c5bcc5e57d50 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Pyrithione 1%

Purpose

Anti-dandruff

Use

Controls the symptoms of dandruff.

Warning

For external use only

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

If condition worsens or does not improve after regular use of the product as directed, consult a doctor.

Directions

Wet hair, lather thoroughly
Leave in 1–2 minutes and rinse well
For best results, use daily or at least twice a week (or as directed by a doctor).

Inactive Ingredients

Water (Aqua), Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Cocamide MIPA, Dimethicone, Zingiber Zerumbet Juice, Clematis Vitalba Leaf Extract, Mahonia Aquifolium Root Extract, Salvia Officinalis (Sage) Leaf Extract, Urtica Dioica (Nettle) Extract, Melia Azadirachta Leaf Extract, Panthenol, Butylene Glycol, Trisodium Ethylenediamine Disuccinate, Acrylates Copolymer, PEG/PPG-18/18 Dimethicone, Hexylene Glycol, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Citric Acid, Sodium Hydroxide, Fragrance (Parfum).

Questions?

1-888-742-7626

PRINCIPAL DISPLAY PANEL - 250 ml Bottle Label

epoch®

Ava puhi moni®

Anti-Dandruff

Shampoo

the "true ava puhi"

250 ml e (8.4 fl. oz.)

Principal Display Panel - 250 ml Bottle Label

INGREDIENTS AND APPEARANCE

EPOCH AVA PUHI MONI ANTI-DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62839-6745
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	65.7 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Sodium Hydroxide (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
Ethylhexylglycerin (UNII: 147D247K3P)
Hexylene Glycol (UNII: KEH0A3F75J)
Panthenol (UNII: WV9CM0O67Z)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
Butylene Glycol (UNII: 3XUS85K0RA)
BERBERIS AQUIFOLIUM ROOT (UNII: 746TB9VNDP)
CLEMATIS VITALBA LEAF (UNII: 526T95850X)
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)
SAGE (UNII: 065C5D077J)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62839-6745-1	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	02/08/2017

Labeler - NSE Products, Inc. (803486393)

Revised: 1/2022

Document Id: faf5eb3a-7c3e-4a6c-b5c9-887883d341f5

Set id: a91a736a-f044-43e7-85f2-c5bcc5e57d50

Version: 2

Effective Time: 20220112