Label: PURELL WATERLESS SURGICAL SCRUB- alcohol liquid

  • NDC Code(s): 21749-992-02, 21749-992-33, 21749-992-89
  • Packager: GOJO Industries, Inc.
  • 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 October 2, 2017

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  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic surgical hand scrub

  • Uses

    Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

  • Warnings

    Flammable. Keep away from fire or flame.

    For external use only

    Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase the risk of sunburn. Take steps to limit sun exposure while using this product and for one week following use.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean under the nails with a nail pick
    • mails should be maintained with a 1 millimeter free edge
    • place 2 mL of product into palm of one hand
    • dip fingers of opposite hand into the product and work under nails
    • spread remaining product evenly over the hands and lower 2/3 of one forearm paying particular attention to the nails, cuticles, and interdigital spaces
    • place 2 mL of product into opposite hand and repeat steps above
    • allow to air dry completely
  • Inactive ingredients

    Water (Aqua), Isopropyl Myristate, Glycerin, Diisopropyl Sebacate, Citric Acid, PEG/PPG-20/6 Dimethicone, Tetradibutyl Pentaerythrityl Hydroxyhydrocinnamate, Hydroxypropylcellulose, Polyquaternium-37, Methylchloroisothiazolinone, Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    PURELL WATERLESS SURGICAL SCRUB 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-992
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-992-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2011
    2NDC:21749-992-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2011
    3NDC:21749-992-891200 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/15/2011
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534MANUFACTURE(21749-992)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.088312414MANUFACTURE(21749-992) , label(21749-992) , pack(21749-992)
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