Label: SOLENTI BIONATURAL HAND SANITIZER- ethyl alcohol spray

  • 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 8, 2021

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  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    For use when soap and water are not available. Helps reduce bacteria on the skin. Recommended for repeated use.

  • Warnings

    For External Use only. Flammable. Keep away from heat or flame

  • Do not Use

    -In 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, flush 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 immediately.

  • Directions

    -Spray 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 above 40C (104F)

  • Inactive Ingredients

    Methylethylglycol, perfume, water

  • Solenti Bio Natural Hand Sanitizer

    60 ml

  • INGREDIENTS AND APPEARANCE
    SOLENTI BIONATURAL HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75794-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL42 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIETHYLENE GLYCOL (UNII: 61BR964293)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75794-100-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    2NDC:75794-100-62185 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - E. Chamorro Industrial, S.A. (852437946)
    Registrant - E. Chamorro Industrial, S.A. (852437946)
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