Label: PROTECT U GUARD 63% FOAMING HAND SANITIZER LEMON- ethyl alcohol liquid
PROTECT U GUARD 63% FOAMING HAND SANITIZER LAVENDER- ethyl alcohol liquid
PROTECT U GUARD 63% FOAMING HAND SANITIZER COTTON- ethyl alcohol liquid
PROTECT U GUARD 63% FOAMING HAND SANITIZER- ethyl alcohol liquid
PROTECT U GUARD 63% FOAMING HAND SANITIZER WATERMELON- ethyl alcohol liquid
PROTECT U GUARD 63% FOAMING HAND SANITIZER FRESH- ethyl alcohol liquid

  • NDC Code(s): 71788-010-10, 71788-010-20, 71788-010-50, 71788-010-60, view more
    71788-010-70, 71788-010-80, 71788-011-10, 71788-011-20, 71788-011-50, 71788-011-60, 71788-011-70, 71788-011-80, 71788-012-10, 71788-012-20, 71788-012-50, 71788-012-60, 71788-012-70, 71788-012-80, 71788-013-10, 71788-013-20, 71788-013-50, 71788-013-60, 71788-013-70, 71788-013-80, 71788-014-10, 71788-014-20, 71788-014-50, 71788-014-60, 71788-014-70, 71788-014-80, 71788-015-10, 71788-015-20, 71788-015-50, 71788-015-60, 71788-015-70, 71788-015-80
  • Packager: Protect U Guard, LLC
  • 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 December 30, 2022

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

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  • Active Ingredient

    Ethanol 63%

  • Purpose

    Antimicrobial

  • Uses

    Hand sanitizer to help reduce bacteria on the skin

    Recommended for repeated use

  • Warnings

    For External Use Only: hands.

    Flammable, keep away from fire or flame.

    When using this product do not use in or near eyes. In case of eye contact, flush thoroughly with water. Do not inhale or ingest.

    Stop use and ask docotr if irritation and redness develops condition persists for more than 72 hours

    Keep out of reach of children. If Swallowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children.

    Stop Use and Ask Doctor

    if irritation and redness develop and persists for more than 72 hours.

  • Directions

    Dispense an adequate amount in your palm to cover all surfaces of hands completely

    Rub hands together until dry

    Supervise children in the use of this product

    Do not consume

  • Other Information

    Do not store above 100 o F (38 o C)

    May discolor some fabrics

  • Inactive Ingredients

    Water, Propylene Glycol, Glycerin, PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer, 2-Perfluorohexylethyl Alcohol, Aloe Barbadensis Leaf Juice (Aloe), Fragrance (Parfum).

  • Questions or comments?

    1-813-815-0530 or www.protectuguard.com

  • PRINCIPAL DISPLAY PANEL

    Hand Sanitizer 18Hand Sanitizer Cotton 18Hand Sanitizer Fresh 18Hand Sanitizer Lavender 18Hand Sanitizer Lemon 18Hand Sanitizer Watermelon 18

  • INGREDIENTS AND APPEARANCE
    PROTECT U GUARD 63% FOAMING HAND SANITIZER LEMON 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)  
    PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71788-011-204 in 1 CARTON08/01/2020
    1NDC:71788-011-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:71788-011-6012 in 1 CARTON08/01/2020
    2NDC:71788-011-50530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:71788-011-8024 in 1 CARTON08/01/2020
    3NDC:71788-011-70100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    PROTECT U GUARD 63% FOAMING HAND SANITIZER LAVENDER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)  
    PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71788-012-204 in 1 CARTON08/01/2020
    1NDC:71788-012-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:71788-012-6012 in 1 CARTON08/01/2020
    2NDC:71788-012-50530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:71788-012-8024 in 1 CARTON08/01/2020
    3NDC:71788-012-70100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    PROTECT U GUARD 63% FOAMING HAND SANITIZER COTTON 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)  
    PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71788-015-204 in 1 CARTON08/01/2020
    1NDC:71788-015-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:71788-015-6012 in 1 CARTON08/01/2020
    2NDC:71788-015-50530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:71788-015-8024 in 1 CARTON08/01/2020
    3NDC:71788-015-70100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    PROTECT U GUARD 63% FOAMING HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)  
    PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71788-010-204 in 1 CARTON08/01/2020
    1NDC:71788-010-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:71788-010-6012 in 1 CARTON08/01/2020
    2NDC:71788-010-50530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:71788-010-8024 in 1 CARTON08/01/2020
    3NDC:71788-010-70100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    PROTECT U GUARD 63% FOAMING HAND SANITIZER WATERMELON 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)  
    PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71788-013-204 in 1 CARTON08/01/2020
    1NDC:71788-013-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:71788-013-6012 in 1 CARTON08/01/2020
    2NDC:71788-013-50530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:71788-013-8024 in 1 CARTON08/01/2020
    3NDC:71788-013-70100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    PROTECT U GUARD 63% FOAMING HAND SANITIZER FRESH 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)  
    PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71788-014-204 in 1 CARTON08/01/2020
    1NDC:71788-014-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:71788-014-6012 in 1 CARTON08/01/2020
    2NDC:71788-014-50530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:71788-014-8024 in 1 CARTON08/01/2020
    3NDC:71788-014-70100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    Labeler - Protect U Guard, LLC (080070945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Protect U Guard, LLC080070945label(71788-010, 71788-011, 71788-012, 71788-013, 71788-014, 71788-015) , manufacture(71788-010, 71788-011, 71788-012, 71788-013, 71788-014, 71788-015)
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