Label: HAND SANITIZER WITH GLYCERIN AND ALOE VERA- 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 March 4, 2022

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

  • Drug Facts

  • Active Ingredients

    Ethyl Alcohol 75% v/v

    Purpose

    Antiseptic

  • Uses:

    Hand Sanitizer to help reduce bacteria on the skin

  • Warnings:

    Flammable. Keep away from heat or flame. For external use only.

    Do not use

    • in children less than 2 months of age
    • on open skin wounds.

    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.

  • Directions:

    • Place enough product on hands to cover all surfaces. Rubs hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information:

    • Store between 15-30°C (59-86°F)
    • May discolor fabrics
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive Ingredients:

    Aqua, Glycerin, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract

  • Package Labeling:

    Bottle3

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WITH GLYCERIN AND ALOE VERA 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78915-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78915-000-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/26/2020
    Labeler - TV Direct LLC (078829674)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Sluj Special Chemical Co., Ltd526847687manufacture(78915-000)