Label: HAND SANITIZER- alcohol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     76795-737-01, 76795-737-02, 76795-737-03, 76795-737-04, view more
    76795-737-05, 76795-737-06, 76795-737-07, 76795-737-09, 76795-737-22, 76795-737-23, 76795-737-25, 76795-737-26, 76795-737-27, 76795-737-28, 76795-737-29
  • Packager: PrintJet Corp
  • 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 October 6, 2020

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

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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

    glycerin, hydrogen peroxide, purified water USP, fragrance, Hydroxypropylcellulose

  • Package Label - Principal Display Panel

    118 ML NDC: 76795-737-26 7679573726Label

    3785 ML NDC: 76795-737-25 3785.41 mL NDC: 76795-737-25

    473 ML NDC: 76795-737-29

    7679573729Label

    236 ML NDC: 76795-737-28 7679573728Label

    236 ML NDC: 76795-737-27 7679573727Label

    118 ML NDC: 76795-737-26 7679573726Label

    3758 ML NDC: 76795-737-25 7679573725Label

    60 ML NDC: 76795-737-01

    60 ml gel

    118 ML NDC: 76795-737-02 overby 7679573702 label

    118 ml gel

    177 ML NDC: 76795-737-03

    177ml gel

    237 ML NDC: 76795-737-04

    237ml gel

    296 ML NDC: 76795-737-09

    296ml gel

    473 ML NDC: 76795-737-05

    473ml gel

    946 ML NDC: 76795-737-06

    946 ml gel

    3785 ML NDC: 76795-737-07 73707 overby3785 ML Gel

    3785 ML NDC: 76795-737-22

    3785 mL NDC 76795-737-22

    946 ML NDC: 76795-737-23 946 mL NDC 76795-737-23

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76795-737
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75.225 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    (2-(((2-(2-AMINO-3-HYDROXY-2-(HYDROXYMETHYL)PROPOXY)-1-HYDROXYPROPYL)HYDROXYPHOSPHORYL)OXY)-1-HYDROXYPROPYL)PHOSPHONIC ACID (UNII: H24O03I2RP) 1.1 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.3 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 22.225 mL  in 100 mL
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.025 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76795-737-073785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    2NDC:76795-737-06946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    3NDC:76795-737-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    4NDC:76795-737-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    5NDC:76795-737-03177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    6NDC:76795-737-04237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    7NDC:76795-737-05473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    8NDC:76795-737-09296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    9NDC:76795-737-223785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    10NDC:76795-737-23946.353 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    11NDC:76795-737-253785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    12NDC:76795-737-26118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    13NDC:76795-737-27237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    14NDC:76795-737-28237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    15NDC:76795-737-29473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/26/2020
    Labeler - PrintJet Corp (158605449)
    Registrant - Sue Sotelo (158605449)
    Establishment
    NameAddressID/FEIBusiness Operations
    PrintJet Corp158605449manufacture(76795-737)
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