Label: ADVANCED HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredients

    Ethyl Alcohol 70%

  • Purpose

    Antibacterial

  • Use

    For rinse-free hand sanitizing to remove 99.9% bacteria on skin

  • Warnings

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

    When using this product

    Do not use in eyes. In case of contact with eyes, rinse with water.

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

    Keep out of reach of children.

    If swallowed, get medical help promptly.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other Information

    Store under 105°F

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Glycerin, Lemon Essential Oil, Purified Water, Tocopheryl Acetate (Vitamin E)

  • PRINCIPAL DISPLAY PANEL

    Safe +
    Palms

    ADVANCED
    HAND SANITIZER

    70% Alcohol

    Gel Formula

    Kills 99.99% of Germs
    and Bacteria

    Hypoallergenic
    Patented Formula

    MADE IN
    USA

    LEMON SCENTED

    16 fl oz (480ml) • safepalms.com

    Package Label
  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90117-102
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Lemon Oil (UNII: I9GRO824LL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90117-102-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    2NDC:90117-102-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    3NDC:90117-102-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    4NDC:90117-102-04480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    5NDC:90117-102-05946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    6NDC:90117-102-061892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/25/2020
    7NDC:90117-102-073785 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(90117-102)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!