Label: EMHS 1 HAND SANITIZER- isopropyl 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 26, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 75% v/v.

  • Purpose

    Antiseptic

  • Use

    To help reduce bacteria that potentially can 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, citrus oil, fragrance, glycerin, rosemary oil, triethanolamine, water

  • Side Panel

    Without rinsing. Non-sticky formula. Disinfecting anti-bacterial gel.

    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.

    WARNINGS: For external use only. Flammable. Keep away from heat or flame. Do not use on children less than 2 months of age or on open skin wounds. Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use if rash or irritation occurs. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Distributed by: Sayida Group LLC

    6538 Collins Ave #401

    Miami Beach, FL33141

    www.emhs1.com

    Made In Mexico

  • Package Label - Principal Display Panel

    Distributed by Sayida Group

    6538 Collins Ave #401

    Miami Beach, FL 33141

    EMHS1 Hand Sanitizer (1L - no pump) NDC: 77858-0755-1

    EMHS1 Hand Sanitizer (1L - pump) NDC: 77858-0755-2

    isop

  • INGREDIENTS AND APPEARANCE
    EMHS 1 HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77858-0755
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77858-0755-11 L in 1 BOTTLE; Type 0: Not a Combination Product06/26/2020
    2NDC:77858-0755-21 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/26/2020
    Labeler - Sayida Group (117520711)
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