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 February 5, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a 70% ethanol unscented gel hand sanitizer with added aloe and vitamin E, manufactured according to FDA guidance. T

  • 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

    glycerin, Rapidgel EZ1, purified water USP

  • Package Label - Principal Display Panel

    118 mL NDC: 79363-706-04

    ProtextRxx 70% Unscented Gel with Aloe and Vit E 4oz

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79363-706
    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
    GLYCERIN (UNII: PDC6A3C0OX) 0.516 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    RAPIDGEL EZ1 (UNII: 33JH4A7R2K) 0.886 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79363-706-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/06/2021
    Labeler - RealChem Manufacturing Inc. (120491681)
    Establishment
    NameAddressID/FEIBusiness Operations
    RealChem Manufacturing Inc117742005manufacture(79363-706) , pack(79363-706) , repack(79363-706)
    Establishment
    NameAddressID/FEIBusiness Operations
    RealChem Manufacturing Inc117828480manufacture(79363-706) , pack(79363-706) , repack(79363-706)
    Establishment
    NameAddressID/FEIBusiness Operations
    RealChem Manufacturing Inc120491681manufacture(79363-706) , pack(79363-706) , repack(79363-706)
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