Label: ADVANCED HAND SANITIZER WITH ALOE BOTTLES- 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 June 15, 2020

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 80%

    Antibacterial Agent

  • Uses.

    Helps reduce bacteria on the skin that can cause sickness, recommended for repeated use.

  • Warnings

    For external use only 

    • Avoid contact with eyes.If contact occurs, flush with water.

    Stop use and ask a doctor 

    if, in rare instances, redness or irritation develops and persists for over 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center.

  • Directions

    Apply a small amount to palms, rubbing briskly to cover both hands until dry-repeat as necessary.

  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Powder, Glycerin, Hydroxypropylcellulose, Hydrogen Peroxide.

  • Package Labeling

    Label

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER WITH ALOE BOTTLES 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77650-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8   in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77650-080-10236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - North Park Enterprises, LC (117130608)
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