Label: PANROSA ALCOHOL-FREE HAND SANITIZER WITH REFRESHING ALOE DUAL ACTION MOISTURIZERS- benzalkonium chloride 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 July 2, 2020

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  • 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 needed 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 discolor fabrics. 
  • Inactive ingredinets

    WATER, HYDROXYETHYLCELLULOSE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA, FRAGRANCE, ALOE BARBADENSIS JUICE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

  • Package Labeling:50302-12-50

    Label

  • Package Labeling:50302-12-23

    Label2

  • Package Labeling:59ml

    Bottle3

  • Package Labeling: 118ml

    Tube

  • INGREDIENTS AND APPEARANCE
    PANROSA ALCOHOL-FREE HAND SANITIZER WITH REFRESHING ALOE DUAL ACTION MOISTURIZERS 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-012
    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)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50302-012-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
    2NDC:50302-012-23237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
    3NDC:50302-012-5959 mL in 1 TUBE; Type 0: Not a Combination Product04/30/2020
    4NDC:50302-012-18118 mL in 1 TUBE; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/13/2020
    Labeler - Panrosa Enterprises, Inc. (859957578)
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