Label: PYURX- disinfectant wet wipes cloth

  • 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 February 8, 2021

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  • SPL UNCLASSIFIED SECTION

    75% Alcohol Disinfectant Wet Wipes. 50 count

  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizing

  • Use

    • For hand sanitizing to decrease bacteria on skin.
    • Recommened for repeated use.
  • Warnings

    • Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
    • Do not use on children less than 2 months of age.
    • For external use only.
    • Flammable Keep away from heat or flame
  • Do not use

    • Do not use in the eyes. In case of contact, rinse thoroughly with water.
    • Do not use on children less than 2 months of age.
  • STOP USE

    • Stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours.
    • Swallowed, get medical help or contact a poison control center right away.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • Children must be supervised when using this product.
  • Directions

    • Wet hands thoroughly with product and allow to dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store at below or below 75F (24C).
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    glycerin, Aqua(water), Vitamin E, Aloe

  • Package Label - Principal Display Panel

    front

    Back

  • INGREDIENTS AND APPEARANCE
    PYURX 
    disinfectant wet wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80527-351
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL  in 100 mL
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.4 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 24 mL  in 100 mL
    ALOE (UNII: V5VD430YW9) 0.3 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80527-351-5150 mL in 1 PACKAGE; Type 0: Not a Combination Product09/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/21/2020
    Labeler - Novara LLC (117659846)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novara LLC117659846relabel(80527-351)
    Establishment
    NameAddressID/FEIBusiness Operations
    NanTong Guarder Medical Technology Co.,Ltd.554537961manufacture(80527-351)
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