Label: PANROSA INSTANT HAND SANITIZER CLEAR- alcohol gel

  • NDC Code(s): 50302-003-00, 50302-003-11, 50302-003-60
  • 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 October 20, 2021

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

  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 70% v/v

    Purpose

    Antiseptic

  • 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 discolor fabrics.
  • Inactive ingredients

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrace, aloe barbadensis leaf juice, tocopheryl acetate

  • Package Labeling:

    Label

  • Package Labeling: 60ml

    Bottle

  • Package Labeling: 1L

    Bottle2

  • INGREDIENTS AND APPEARANCE
    PANROSA INSTANT HAND SANITIZER CLEAR 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50302-003-00237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/21/2020
    2NDC:50302-003-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    3NDC:50302-003-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/21/2020
    Labeler - PANROSA ENTERPRISES, INC. (859957578)