Label: PANROSA ALCOHOL FREE HAND SANITIZER- benzalkonium chloride gel

  • NDC Code(s): 50302-004-00, 50302-004-01
  • Packager: Panrosa Enterprises, Inc.
  • 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 6, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    • hand sanitizer to help decrease bacteria on the skin. when water, soap & towel are not available. 
    • recommended for repeated use.
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not apply around eyes.

    Do not use

    in ears & mouth.

    When using this product,

    avoid contact with eyes. In case of contact flush eyes with water.

    Stop use and ask a doctor if 

    redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

  • Directions

    • pump as need into your palms and thoroughly spread on both hands.
    • rub into skin until dry.
  • Other information

    • store at 20°C (68°F to 77°F).
    • may dscolor fabrics.
  • Inactive ingredients

    Water, Cetrimonium Chloride, Lauramine Oxide, Cocamide Methyl MEA, Sodium Chloride, Propanediol, Parfum (Fragrance), Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone.

  • Package Labeling: 50302-004-00

    Label

  • Package Labeling: 50302-004-01

    Label2

  • INGREDIENTS AND APPEARANCE
    PANROSA ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-004
    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
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50302-004-00296 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
    2NDC:50302-004-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/09/2020
    Labeler - Panrosa Enterprises, Inc. (859957578)
    Establishment
    NameAddressID/FEIBusiness Operations
    Panrosa Enterprises, Inc.859957578manufacture(50302-004)