Label: CHEVANCE- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 21, 2015

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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)