Label: SHILLS ACNE PURIFYING PEEL OFF BLACK MASK- pyrithione zinc solution

  • 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 April 28, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Pyrithione Zinc  0.95%

  • PURPOSE

    Purpose:

    Acne Treatment

  • INDICATIONS & USAGE

    Uses:

    Thoroughly clears blackheads and surface dirts. Tear off formulation prevents pores from clogging and deeplycleanes the face thoroughly

  • WARNINGS

    Warning:

    Aviod direct contact with eyes. If contacts occurs, please rinse thoroughly with water. If skin shows allergic reaction, please st5op use immediately. For external use only.

  • ASK DOCTOR

    Stop use and ask a doctor If

    rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children

  • DOSAGE & ADMINISTRATION

    Directions:

    Dry the cleansed area and apply the mask on direct area (avoid eyebrow, eyes, and lips). Peel it off and 20-30 minutes. To achieve better results, apply toner so as to tighten and cleanse the pores thoroughly.

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Purified Water,  Glycerin, Charcoal Powder, Polyvinyl Alcohol, Biosaccharide Gum-1, Phenoxyethanol, Caprylyl Glycol, Xanthan Gum, Aloe Extract, Rosa Damascena Flower Oil, DMDM Hydantoin, 3-Iodo-2-Propynyl Butyl Carbamate, Butane-1,3-diol, Aveva Sativa (Oat) Kernel Extract, Grapefruit Extract, Soluble Collagen

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SHILLS ACNE PURIFYING PEEL OFF BLACK MASK 
    pyrithione zinc solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71696-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.95 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE (UNII: V5VD430YW9)  
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71696-001-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/28/2017
    Labeler - Lin Quan Enterprises Co., Ltd. (658514971)
    Registrant - Lin Quan Enterprises Co., Ltd. (658514971)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lin Quan Enterprises Co., Ltd.658514971manufacture(71696-001)
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