Label: PANROSA INSTANT HAND SANITIZER ALOE VERA- alcohol 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 October 20, 2021

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  • Drug Facts

  • Active ingredient

    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

    • place enough product into your palms and thoroughly spread on both hands.
    • rub into skin until dry.
  • Other information

    • store below 110 ℉ (43℃ ). 
    • may discolor certain fabrics or surfaces.
  • Inactive ingredients

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate, FD&C blue No. 1, FD&C yellow No. 5.

  • Package Labeling:50302-013-10

    Bottle5

  • Package Labeling:50302-013-60

    Bottle6

  • INGREDIENTS AND APPEARANCE
    PANROSA INSTANT HAND SANITIZER ALOE VERA 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50302-013-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2020
    2NDC:50302-013-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/06/2020
    Labeler - Panrosa Enterprises, Inc. (859957578)
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