Label: CUSTOM QUEST HAND SANITIZER- alcohol liquid

  • 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 14, 2022

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  • Drug Facts

  • Active ingredient

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand Sanitizer to help reduce bacteria that potentially can cause disease  • for use when soap and water are not available

  • Warnings

    Flammable, keep away from fire/flame
    For external use only

    Do not use   • in the eyes  • on children less than 2 years of age  • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor if  • irritation and redness develop  • 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.

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping  • supervise children under 6 years of age when using this product

  • Other information

    • store between 15-30°C (59-86°F)   • avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    Aloe (Aloe barbadensis) Leaf Juice, Carbomer, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water

  • Questions?

    +1-513-644-0445

    You may also report serious side effects to this phone number.

    Monday through Friday, 8:30 am-4:30 pm Eastern Standard Time

  • SPL UNCLASSIFIED SECTION

    with ALOE VERA

    Antibacterial

    Distributed by:

    Custom Quest, Inc

    6511 West Chester Rd.

    West Chester, OH 45069

    MADE IN CHINA

  • Packaging

    237 mL

  • INGREDIENTS AND APPEARANCE
    CUSTOM QUEST HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74876-654
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74876-654-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    2NDC:74876-654-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/202012/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Custom Quest, Inc. (049451540)
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