Label: 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 1, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • 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 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 right away.

  • STOP USE

    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

    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

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    purified water USP, glycerin, carbomer, triethanolamine.

  • Package Label - Principal Display Panel

    500 mL NDC: 77252-003-01 Kingspoint Gel 70% 500 mL

    Urgent RN 70% 500 mL

    1000 mL NDC: 77252-003-02

    Kingspoint 500mL

    SIEGEL1L

    4000 mL NDC: 77252-003-03 etiqueta 4L

    3780mL NDC 77252-003-04

    SIEGEL1GAL

    60mL NDC 77252-003-05

    Medply 60mL PDP

    Medply 60 mL IP

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77252-003
    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
    CARBOMER 940 (UNII: 4Q93RCW27E) 3 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
    TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK) 1 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77252-003-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:77252-003-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:77252-003-034000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:77252-003-043780 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:77252-003-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - SERVICIOS INTEGRADOS DE ENVASADO SA DE CV (812822219)
    Registrant - SERVICIOS INTEGRADOS DE ENVASADO SA DE CV (812822219)
    Establishment
    NameAddressID/FEIBusiness Operations
    SERVICIOS INTEGRADOS DE ENVASADO SA DE CV812822219manufacture(77252-003) , pack(77252-003) , label(77252-003)
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