Label: ELEMENTS ETHANOL 75% HAND SANITIZER WIPES- 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 July 20, 2020

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  • ACTIVE INGREDIENT

    ethyl alcohol

  • PURPOSE

    Hand sanitizing wipes to help reduce bacteria that potentially can cause disease

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • WARNINGS

    ■ Flammable. Keep away from fire or flame.

    ■ For external use only.

    ■ Do not use in eyes.

    ■ lf swallowed, get medical help promptly.

    ■ Stop use, ask doctor lf irritation occurs.

    ■ Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    for external use only

  • INACTIVE INGREDIENT

    Water, Dipropylene Glycol, Fragrance, Aloe Extract

  • INDICATIONS & USAGE

    ■ Wet hands thoroughly with product and allow to dry without wiping

    ■ Do not flush

    ■ Children under 2 years ask a doctor before use

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ELEMENTS ETHANOL 75% HAND SANITIZER WIPES 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74200-0031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74200-0031-180 g in 1 PACKAGE; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2020
    Labeler - URBANBCL CO LTD (694794065)
    Registrant - URBANBCL CO LTD (694794065)
    Establishment
    NameAddressID/FEIBusiness Operations
    URBANBCL CO LTD694794065manufacture(74200-0031)
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