Label: SOLGREAT ANTIBACTERIAL HANDWASH- benzalkonium chloride liquid

  • 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 March 27, 2020

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  • Active lngredient  

    Benzalkonium Chloride

  • Purpose

    Antibacterial

  • Uses

    • for handwashing to decrease bacteria on the skin.
  • Warnings For external use only.

    When using this product, avoid contact with eyes. In case of eye contact, flush with water.

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • place enough product into your palms, wet as needed.
    • lather vigorously for at least 20 seconds.
    • wash skin, rinse and dry thoroughly.

  • Inactive ingredients

    Cetrimonium Chloride, Cocamide Methyl MEA, Lauramine Oxide, Methylchoroisothiazolinone, Methylisothiazolinone, Parfum (Fragrance), Propanediol, Sodium Chloride, Tocopheryl Acetate, FD&C Yellow No. 5, FD&C Red No. 4, Water.

  • Product Label237mL  SolGreat Antibacterial Hand Soap

    237mL

  • Product Label - 500mL SolGreat Antibacterial Hand Soap

    500mL

  • INGREDIENTS AND APPEARANCE
    SOLGREAT ANTIBACTERIAL HANDWASH 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73913-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cetrimonium chloride (UNII: UC9PE95IBP)  
    COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73913-003-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    2NDC:73913-003-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/23/2020
    Labeler - PANATURAL USA, INC. (029572239)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hefei Yatai Daily-Use Chemical Industry Co., Ltd654641724manufacture(73913-003)
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