Label: CHEVANCE- pyrithione zinc shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 70053-010-01 - Packager: Yes Miracle Ltd
- 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
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- ACTIVE INGREDIENT
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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
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHEVANCE
pyrithione zinc shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70053-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrithione Zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) Pyrithione Zinc 5.8 mg in 290 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70053-010-01 290 mL in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/01/2015 Labeler - Yes Miracle Ltd (689517176) Registrant - Yes Miracle Ltd (689517176) Establishment Name Address ID/FEI Business Operations Yes Miracle Ltd 689517176 manufacture(70053-010)