Label: MALBON - HAND SANITIZER- alcohol spray

  • 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 May 20, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS:

  • ACTIVE INGREDIENTS

    Ethyl Alcohol 71% v/v

  • Purpose

    Antimicrobial

  • USES

    Hand sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

  • WARNINGS

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

    • When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    • Stop use and seek a doctor if redness or irritation develops and persists for more than 72 hours.

    • Keep out of reach of children. Children under 6 years of age should be supervised when using this product. If swallowed, get medical help or contact a Poison Control Center right away.
  • DIRECTIONS

    Put enough product in your palm to cover hands and rub hands together briskly until dry.

  • INACTIVE INGREDIENTS

    Water (Aqua), Glycerin, Propanediol, Sodium Hyaluronate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylic/Capric Triglyceride, Tocopherol, Carthamus Tinctorius Oleosomes, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Fragrance.

  • OTHER INFORMATION

    Store at 68°F to 77°F (20° to 25° C). May discolor fabrics.

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    Malbon

    hand sanitizer spray

    kills 99.9% of most germs
    2 Fl. Oz | 60mL

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MALBON - HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-1602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol71 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propanediol (UNII: 5965N8W85T)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Tocopherol (UNII: R0ZB2556P8)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    Trolamine (UNII: 9O3K93S3TK)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-1602-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A04/01/2020
    Labeler - Cosmetic Solutions LLC (807907928)
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