HAND SANITIZER ALOE VERA (ALCOHOL) GEL [PANROSA ENTERPRISES, INC.]

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HAND SANITIZER ALOE VERA (ALCOHOL) GEL [PANROSA ENTERPRISES, INC.]
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NDC 50302-001-00
Set ID 9a32e4d9-9d21-4ab9-9c9c-50261dd8aa4b
Category HUMAN OTC DRUG LABEL
Packager Panrosa Enterprises, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 62%

    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℃ (68℉ to 77℉).
    • may discolor fabrics.
  • Inactive ingredients

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

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER ALOE VERA 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50302-001-00237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2019
    Labeler - Panrosa Enterprises, Inc. (859957578)
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