Label: EMHS1 HAND SANITIZER- alcohol gel

  • 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 16, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Use

    To help reduce bacteria that can potentially cause disease.

  • 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

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs.

  • 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.

  • 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

    Do not store above 43C (110F)

  • Inactive ingredients

    Carbomer, Isopropyl alcohol, Quaternary ammonium, Water

  • Package Label - Principal Display Panel

    DISTRIBUTED BY: Sayida Group

    6538 Collins Ave #401

    Miami Beach, FL 33141

    EMHS1 Hand Sanitizer (bottle, pump - 1L) NDC: 77858-0754-1

    EMHS1 Hand Sanitizer (bottle - 1L) NDC: 77858-0754-2

    Liter

  • INGREDIENTS AND APPEARANCE
    EMHS1 HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77858-0754
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77858-0754-11 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/16/2020
    2NDC:77858-0754-21 L in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/11/2020
    Labeler - Sayida Group LLC (117520711)
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