Label: PROSANA SKIN AND BODY- ethanol gel

  • NDC Code(s): 81441-001-01, 81441-001-02, 81441-001-03, 81441-001-04, view more
    81441-001-05, 81441-001-06, 81441-001-07
  • Packager: Bodywell Natural Skin Care 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 April 24, 2023

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  • Active Ingredients

    Ethanol 70%

  • Purpose

    Antiseptic.

  • Uses

    • Hand Sanitizer to help reduce bacteria that potentially can cause disease. 
    • For use when soap and water are not available.
  • Warnings

    For external use only Flammable. Keep away from heat or flame.

    Do not use• in children less than 2 months of age.
    • on open skin or wounds.

    When using this product keep out of eyes, earsand mouth. In case of contact with eyes, rinseeyes thoroughly with water.

    Stop use and ask a doctor

    • if irritation occurs.
    • These may be signs of a serious condition.
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions.

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information.

    • Store between 15-30C (59-86F)
    • Avoid freezing & excessive heat above 40C(104F)

  • Inactive Ingredients.

    Aqua, Aloe Barbadensis (Aloe Vera) Leaf Juice,Glycerin, Isopropyl Myristate, Propylene Glycol,
    Tocopheryl Acetate (Vitamin E), Aminoethyl Propanol, Carbomer, Fragrance.

  • Product Label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    PROSANA SKIN AND BODY 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81441-001
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81441-001-01473 mL in 1 PACKAGE; Type 0: Not a Combination Product01/04/2021
    2NDC:81441-001-023785 mL in 1 PACKAGE; Type 0: Not a Combination Product02/09/2021
    3NDC:81441-001-03946 mL in 1 PACKAGE; Type 0: Not a Combination Product02/09/2021
    4NDC:81441-001-04473 mL in 1 PACKAGE; Type 0: Not a Combination Product02/09/2021
    5NDC:81441-001-05177 mL in 1 PACKAGE; Type 0: Not a Combination Product02/09/2021
    6NDC:81441-001-0688 mL in 1 PACKAGE; Type 0: Not a Combination Product02/09/2021
    7NDC:81441-001-073 mL in 1 PACKET; Type 0: Not a Combination Product04/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/04/2021
    Labeler - Bodywell Natural Skin Care Inc (201162026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bodywell Natural Skin Care Inc201162026manufacture(81441-001)
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