Label: CLINICAL WORKS PINK GRAPEFRUIT WATERLESS HAND SANITIZER- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 5, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients
    Ethyl Alcohol 62%

    Purpose
    Antisepic
  • DESCRIPTION

    Uses

    • To decrease bacteria on the skin that could cause disease.
    • Recommended for repeated use
  • WARNINGS

    Warnings

    For external use only-hands. 
    Flammable. Keep away from heat and flame.
    When using this product, Keep out of eyes. In case of contact with eyes, flush thoroughly with water.  Avoid contact with broken skin. Do not inhale or ingest.
    Stop use and ask a doctor if skin irritation develops.
    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Directions

    Wet hands thoroughly with product and allow to dry without wiping.
    For children under 6,use only under adult supervision.
    Not recommended for infants.
  • WARNINGS AND PRECAUTIONS

    Other Information

    Do not store above 105F
    May discolor some fabrics.
    Harmful to wood finishes and plastics
  • INACTIVE INGREDIENT

    Inactive Ingredients

    water(Aqua), Glycerin, Triethanolamine, Carbomer, Fragrance(parfum), PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, FD and C Yellow No. 5, FD and C Blue No. 1, FD and C Red No. 40

  • PRINCIPAL DISPLAY PANEL

    labepicture

  • INGREDIENTS AND APPEARANCE
    CLINICAL WORKS PINK GRAPEFRUIT WATERLESS HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50593-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.000 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 35.39999 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 1.0 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.25 g  in 100 g
    CARBOMER 934 (UNII: Z135WT9208) 0.25 g  in 100 g
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.4 g  in 100 g
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) 0.5 g  in 100 g
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.000004 g  in 100 g
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.000002 g  in 100 g
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.000004 g  in 100 g
    GRAPEFRUIT (UNII: O82C39RR8C) 0.2 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50593-007-0160 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33306/10/2010
    Labeler - Taizhou Xinzhixuan Daily-Use Co., Ltd. (420438920)
    Registrant - Taizhou Xinzhixuan Daily-Use Co., Ltd. (420438920)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Xinzhixuan Daily-Use Co., Ltd.420438920manufacture
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