Label: HAND SANITIZER 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 September 23, 2020

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  • DOSAGE & ADMINISTRATION

    ●store between 15- 40°C (59-104°F)
    ●Avoid freezing and excessive heat above 40°C(104°F)

  • INACTIVE INGREDIENT

    WATER,CARBOMER,TRIETHANOLAMINE,CI 17200,CI 51319,CI 42090,CI 74260

  • INDICATIONS & USAGE

    Place enough product on hands to cover all surfaces.Rub hands together until dry.

  • ACTIVE INGREDIENT

    ALCOHOL

  • PURPOSE

    Disinfe ction
    Sterilization
    No Rinseing

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children,If swallowed,get medicalhelp or contact a poison control center right away.

  • WARNINGS

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52965-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.5 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PIGMENT VIOLET 23 (UNII: 8U8Z6628KF)  
    PIGMENT GREEN 7 (UNII: BPO9294G4W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52965-010-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product09/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/24/2020
    Labeler - Guangzhou Da'ao Cosmetics Co., Ltd (529652672)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Da'ao Cosmetics Co., Ltd529652672manufacture(52965-010)
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