Label: MODESA HAND SANITIZER 2 FL.OZ. 3 PK- ethyl alcohol 70.0% v/v 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 26, 2019

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethyl Alcohol 70.0% v/v

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
  • WARNINGS

    Warnings

    For external use only

    Flammable, keep away from heat and flame.

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

  • ASK DOCTOR

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product
    • Briskly rub hands together until dry
    • Supervise children under 6 years in the use of this prodyuct
  • OTHER SAFETY INFORMATION

    Other information

    • Store at room temperature
    • May discolor certain fabrics
  • INACTIVE INGREDIENT

    Inactive ingredients

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    MODESA HAND SANITIZER 2 FL.OZ.  3 PK
    ethyl alcohol 70.0% v/v liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-120
    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 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-120-013 in 1 BOX06/27/2019
    1NDC:58503-120-0059.2 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/27/2019
    Labeler - China Ningbo Shangge Technology Co., Ltd. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Technology Co., Ltd.529287434manufacture(58503-120)
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