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 August 18, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 62.5% v/v…………………..……... Antiseptic

  • 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 fire or flame, heat, sparks, and sources of static discharge

  • Do not use

    In eyes | on children less than 2 months of age | on open skin wounds

  • When Using

    If in eyes, rinse promptly and thoroughly with water | Discontinue use if irritation and redness Develops

  • Stop use and ask a doctor

    if skin irritation or redness occurs

    or 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.

  • Directions

    Apply product onto hands, spread thoroughly and

    rub dry | Supervise children under 6 years of age when using

    this product to avoid swallowing.

  • Other information

    Other Information For additional information, see Safety Data

    Sheets (SDS) | For emergency medical information in USA and

    Canada, call 1-888-255-3924 | Store between 15-

    30C (59-86F) | Avoid freexing and excessive heat above 40C

    (104F)


    ​

  • Inactive ingredients

    water (aqua), propylene glycol,

    dimethicone PEG-7 Isostearate, acrylates/ C10-30 Alkyl

    Acrylate Crosspolymer, aminomethylpropanediol, tocopherol

    acetate, aloe barbadensis leaf juice

  • Purpose

    ​Antiseptic, Hand Sanitizer

  • Package Label - Principal Display Panel

    1893 mL NDC: 79436-101-06946 mL NDC: 79436-101-05236.5 mL NDC: 79436-101-03236.5 mL NDC: 79436-101-03

    473 mL NDC: 79436-101-04473 mL NDC: 79436-101-04

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79436-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE (UNII: V5VD430YW9)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    PPG-14 BUTYL ETHER (UNII: R199TJT95T)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    DIMETHICONE PEG-7 ISOSTEARATE (UNII: JVS3399FNW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79436-101-0410000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2020
    2NDC:79436-101-0330000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/19/2020
    3NDC:79436-101-0510000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/19/2020
    4NDC:79436-101-0610000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/19/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Oingo Products LLC (117510957)
    Registrant - Oingo Products LLC (117510957)
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