CHEVANCE

Main information

  • Trade name:
  • CHEVANCE- pyrithione zinc shampoo
  • Composition:
  • Pyrithione Zinc 5.8 mg in 290 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHEVANCE- pyrithione zinc shampoo
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Purpose: Scalp Protectant Indications & Usage: After get the hair and scalp thoroughly moistened with warm water and take a moderate amount of shampoo to evenly apply the scalp and massage and produce foam. Wait 3 minutes, and then wash it thoroughly.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 70053-010-01
  • Last update:
  • 30-05-2019

Summary of Product characteristics: dosage, interactions, side effects

CHEVANCE- pyrithione zinc shampoo

Yes Miracle Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ACTIVE INGREDIENT

Active Ingredient: Zinc Pyrithione 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Sodium Cocoyl

Glutamate, Cocamide DEA, Lauramide DEA, Coix Lacryma-Jobi Ma-yuen Seed Extract, Biotin,

Niacinamide, Panthenol, Pantolactone, Glycyrrhiza Glabra (Licorice) Root Extract, Sophora

Angustifolia Root Extract, Zizyphus Jujuba Fruit Extract, Angelica Keiskei Extract, Morus Alba Bark

Extract, Acorus Gramineus Root/Stem Extract, Pinus Densiflora Extract, Artemisia Vulgaris Extract,

Houttuynia Cordata Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Perilla

Frutescens Leaf Extract, Camellia Sinensis Leaf Extract, Paeonia Albiflora Root Extract, Citrus Unshiu

Peel Extract, Cnidium Officinale Root Extract, Polyquaternium-10, Citric Acid, Sodium Citrate,

Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance

PURPOSE

Purpose: Scalp Protectant

WARNINGS

Warnings: Precautions for Shampoo 1.Do not use in the scalp with wound, sash, etc. 2.Side effects : If

you have hypersensitivity sush as rash, irritation or itching due to the use of the shampoo, please

discontinue use and consult pharmacist or doctor. 3.General Precautions 1)Take care not to let it get into

eyes. If it gets into the eyes, wash thoroughly with water. Get medical treatment from eye doctor if

these symptoms are severe. 2)Do not use for internal use but for external use only. 4.Precautions for

Storage and Handling 1)Avoid direct sunlight and keep in a less moist and cool place if possible.

2)Avoid the misuse and do not put into different containers to maintain the quality. 3)Keep away near a

fire and keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: After get the hair and scalp thoroughly moistened with warm water and take a

moderate amount of shampoo to evenly apply the scalp and massage and produce foam. Wait 3 minutes,

and then wash it thoroughly.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use once a day. 5ml for one-time use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHEVANCE

pyrithione zinc shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 53-0 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Pyrithio ne Zinc (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9 53O2RHZ5)

Pyrithio ne Zinc

5.8 mg in 29 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Co ca mido pro pyl Beta ine (UNII: 5OCF3O11KX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 0 53-0 10 -0 1 29 0 mL in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

Yes Miracle Ltd

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 7/0 1/20 15

Labeler -

Yes Miracle Ltd (689517176)

Registrant -

Yes Miracle Ltd (689517176)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Yes Miracle Ltd

6 8 9 517176

ma nufa c ture (70 0 53-0 10 )

Revised: 8/2015