Label: UNIVERSITY MEDICAL PHARMACEUTICALS 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 May 9, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use(s)

    ■ Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do Not Use

    ■ on children less than 2 months of age ■ on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctorif irritation or rash occurs. These may be signs of a serious condition.

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

  • Directions

    ■ Place enough product on hands to cover all surfaces. Rub hands together until dry.

    ■ Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    ■ Store between 15-30°C (59-86°F)

    ■ Avoid freezing and excessive heat above 40°C (104°F)

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Glycerin, Tocopheryl Acetate, Purified Water.

  • SPL UNCLASSIFIED SECTION

    NEW

    REDUCE BACTERIA THAT POTENTIALLY CAUSE DISEASE

    KEEPS HANDS FEELING FRESH AND SOFT

    Questions? Call toll free 855-299-8800

    Distributed by UNIVERSITY MEDICAL PHARMACEUTICALS CORP
    universitymedical.com | 9671 Irvine Center Drive, Irvine, CA 92618

    ©2020 All rights reserved. Made in USA.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    UNIVERSITY MEDICAL PHARMACEUTICALS HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-888
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50544-888-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - University Medical Pharmaceuticals Corp. (809706252)
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