Label: JOLO ACTIVE- 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 September 11, 2020

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  • Active ingredient

    Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Use

    To sanitize hands without requiring water or a rinse – Kills 99.9% of most common bacteria in 15 seconds

  • Warnings

    For external use only

    Flammable

    Do not use near heat or flame

    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 throughly with water.

    Stop use and ask a doctor

    if irritation or rash occurs.

    They 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 atv 1-800-222-1222

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Apply gel liberally to unsoiled hands and rub in thoroughly

    Allow to dry without wiping or rinsing

  • Other information

    • Store at room temperature.
  • Inactive ingredients

    Water, Aloe barbadensis Leaf Juice, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, Yellow 10, Yellow 5, Blue 1.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    JOLO ACTIVE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79989-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79989-001-01150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/2020
    Labeler - FUSION ACCELERATE, LLC (081331914)
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