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.

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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

Image of carton

CHEVANCE 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70053-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) Pyrithione Zinc5.8 mg  in 290 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70053-010-01290 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/01/2015
Labeler - Yes Miracle Ltd (689517176)
Registrant - Yes Miracle Ltd (689517176)
Establishment
NameAddressID/FEIBusiness Operations
Yes Miracle Ltd689517176manufacture(70053-010)

Revised: 8/2015
Document Id: 7dc87b3f-74dc-41b4-8591-c610ae345349
Set id: f9356a62-cbab-4a0e-911f-9ab7bd43a989
Version: 1
Effective Time: 20150821
 
Yes Miracle Ltd