Label: INSTANT HAND SANITIZER- alcohol liquid

  • NDC Code(s): 59898-420-01, 59898-420-02, 59898-420-03, 59898-420-04, view more
    59898-420-10, 59898-420-11, 59898-420-12, 59898-420-13, 59898-420-14, 59898-420-15, 59898-420-16, 59898-420-17, 59898-420-28, 59898-420-33, 59898-420-36
  • Packager: Water-Jel Technologies
  • 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 January 2, 2023

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  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • to help reduce bacteria on the skin
  • Warnings

    For external use only

    Flammable, keep away from fire or flame

    When using this product

    • do not use in the eyes
    • discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children

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

  • SPL UNCLASSIFIED SECTION

    • store at 15 0 to 25 0 C (59 0 to 77 0 F)
    • may discolor certain fabrics or surfaces
    • you may report a serious adverse reaction to this product to 800-275-3433
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate, fragrance, PEG-60 almond glycerides, propylene glycol, tocopheryl acetate, purified water, triisopropanolamine

  • Questions

    info@safeguardmedical.com www.safeguardmedical.com

  • Directions

    • place enough product in your palm to thoroughly cover your hands. Rub hands together until dry.
    • for children under 6 years of age, use only under adult supervision. Not recommended for infants.
  • Principal Display Panel

    Enter section text here Hand Sanitizer labeling

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-420
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-420-1524 in 1 CARTON04/15/201006/30/2022
    1NDC:59898-420-14240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59898-420-1324 in 1 CARTON04/15/201106/30/2022
    2NDC:59898-420-12118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:59898-420-1124 in 1 CARTON04/15/201106/30/2022
    3NDC:59898-420-1059 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:59898-420-02144 in 1 BOX, UNIT-DOSE04/15/2011
    41.3 mL in 1 PACKET; Type 0: Not a Combination Product
    5NDC:59898-420-011728 in 1 CARTON04/15/2011
    51.3 mL in 1 PACKET; Type 0: Not a Combination Product
    6NDC:59898-420-0325 in 1 BOX, UNIT-DOSE04/15/2011
    61.3 mL in 1 PACKET; Type 0: Not a Combination Product
    7NDC:59898-420-333000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/201106/30/2022
    8NDC:59898-420-2830 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/201106/30/2022
    9NDC:59898-420-1724 in 1 CARTON04/15/201106/30/2022
    9NDC:59898-420-16240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    10NDC:59898-420-360.9 mL in 1 PACKAGE; Type 0: Not a Combination Product04/15/2010
    11NDC:59898-420-0410 in 1 CARTON04/15/2010
    110.9 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/15/2010
    Labeler - Water-Jel Technologies (155522589)
    Registrant - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-420)
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