Label: JOJO SIWA HAND SANITIZER- benzalkonium chloride 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 October 28, 2019

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use To help reduce bacteria and germs on the skin.

  • WARNINGS

    WARNING Flammable. Keep away from fire or flame. For external use only • Stop use and ask a doctor if irritation or redness develops and persists.

    • Keep out of reach of children. • In case of accidental digestion, seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions • Place enough product in palm to cover hands and rub hands together briskly until dry.

    • Children under 6, use only under adult supervision.

    • Not recommended for infants.

  • STORAGE AND HANDLING

    Other Information • Do not store above 100° F (38° C). • May discolor some fabrics. • Harmful to wood finishes and plastics.

  • INACTIVE INGREDIENT

    Inactive Ingredients • Aqua (Water), Hydroxyethylcellulose, Phenoxyethanol, Disodium EDTA, Polysorbate 20, Parfum (Fragrance).

  • SPL UNCLASSIFIED SECTION

    Smart Care®

    ©2019 Viacom International Inc. Al Rights Reserved. Nickelodeon and all related titles and logos are trademarks of Viacom International Inc. JoJo Siwa is a trademark of JoJo Siwa Entertainment, LLC.

    QUESTIONS OR COMMENTS?    

    1-877-274-8358 Toll Free in USA • 1-909-434-0911 International COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    JOJO SIWA HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-022-0153 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2019
    Labeler - Ashtel Studios, Inc. (148689180)
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