Label: UCARE HAND SANITIZER- ethyl alcohol solution

  • 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 28, 2020

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  • Drug Facts

  • Active ingredient[s]

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use[s] Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS

    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 doctor if 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 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive ingredients deionized water, carbomer, glycerin, triethanolamine

  • SPL UNCLASSIFIED SECTION

    ucare FOUNDATION

    Non-Sterile Solution

    Moisturize your hands while decreasing bacteria.

    usmooth

    UNEXPECTED LUXURY

    Springfield, MO 65803

    Made in USA

    usmooth.com

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    UCARE HAND SANITIZER 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78086-905
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78086-905-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/23/2020
    2NDC:78086-905-04118.3 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2020
    3NDC:78086-905-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2020
    4NDC:78086-905-85250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2020
    5NDC:78086-905-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2020
    6NDC:78086-905-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2020
    7NDC:78086-905-641892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2020
    8NDC:78086-905-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/23/2020
    Labeler - Open Door Packaging, Llc (079129996)
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