Label: 4 YOUR SAFETY HAND SANITIZER- alcohol gel

  • NDC Code(s): 79252-001-01, 79252-001-02, 79252-001-03, 79252-001-04
  • Packager: Montenegro Castro, Carlos
  • 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 August 10, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient[s]

    Ethyl Alcohol 70% v/v

    Purpose

    Antimicrobial

  • Use[s]

    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 this product

    keep out of eyes, ears and mouth. In case of contact with eyes, rinse 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.

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

    Glycerin, Carbomer, Purified Water

  • Package Labeling:60ml

    Bottle

  • Package Labeling:250ml

    Bottle2

  • Package Labeling:500ml

    Bottle3

  • Package Labeling:1000ml

    Bottle4

  • INGREDIENTS AND APPEARANCE
    4 YOUR SAFETY HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79252-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79252-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    2NDC:79252-001-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    3NDC:79252-001-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    4NDC:79252-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/30/2020
    Labeler - Montenegro Castro, Carlos (951577488)