Label: DISPOSABLE HAND SANITIZER- alcohol free hand sanitizer 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 August 6, 2020

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  • DOSAGE & ADMINISTRATION

    Do not store above 110°F(43° C).

  • INACTIVE INGREDIENT

    Deionized Water，Glycerin，Propylene Glycol，Methylparaben, Phenoxyethanol

  • INDICATIONS & USAGE

    Place enough product on hands to cover all surfaces. Rub hands together until dry. No rinsing required.

  • ACTIVE INGREDIENT

    Benzalkonium Chloride

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1.Keep away from children.
    2.For external use only.
    3.Keep out of eyes. If contacts eyes, flush with water and call a doctor.
    4.If irritation or rash: appears and persists, stops use and see a physician.
    5.Do not store above 110°F(43° C)
    6.If swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DISPOSABLE HAND SANITIZER 
    alcohol free hand sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55297-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.65 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55297-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/22/2020
    Labeler - Ningbo Salix Hygiene Products Co., Ltd. (554541182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Salix Hygiene Products Co., Ltd.554541182manufacture(55297-001)
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