Label: ADVANCED HAND SANITIZER- benzalkonium chloride 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 August 25, 2020

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  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin that can cause disease.

  • Warnings

    For external use only.

    When using this product avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness appears and lasts

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Apply liberally to front and back of hands. Allow to dry. Repeat daily.

  • Other Information

    Store above 0°C (32°F)

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Caesalpinia Spinosa Gum, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Purified Water

  • PRINCIPAL DISPLAY PANEL

    Safe +
    Palms

    ADVANCED
    HAND SANITIZER

    NON-ALCOHOL

    Gel Formula

    Kills 99.99% of Germs
    and Bacteria

    Hypoallergenic
    Patented Formula

    MADE IN
    USA

    16 fl oz (480ml) • safepalms.com

    Package Label
  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90117-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90117-201-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    2NDC:90117-201-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    3NDC:90117-201-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    4NDC:90117-201-04480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    5NDC:90117-201-05946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    6NDC:90117-201-061892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    7NDC:90117-201-073785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2020
    Labeler - Safe Palms, LLC (117609055)
    Establishment
    NameAddressID/FEIBusiness Operations
    Music City Laboratories, Llc117409349MANUFACTURE(90117-201)
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