Label: SANISMART 3- ethanol liquid

  • 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 March 14, 2018

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  • ACTIVE INGREDIENT

    Active ingredient

    Ethanol 70%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses    •For hand washing to decrease bacteria on the skin

                •Recommended for repeated use

  • WARNINGS

    Warnings

    For external use only.

    Flammable, keep away from fire or flame.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes

    thoroughly with water.

    Stop use and ask a doctor if irritation or redness develop, or if condition persists for more

    than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a

    Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions    •Dispense an adeqaute amount in your palm to cover all surfaces of hands

    completely.    •Rub hands together until dry   •Supervise children in the use of this product.

  • STORAGE AND HANDLING

    Other information   •Do not store above 100° F (38° C)   •May discolor some fabrics

  • INACTIVE INGREDIENT

    Inactive ingredients   Water (Aqua), Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf

    Juice Panthenol

  • QUESTIONS

    Questions or comments?   781-03-7800   •info@registeredchemicals.com

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SANISMART 3 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72130-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72130-003-011250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2018
    2NDC:72130-003-021000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2018
    3NDC:72130-003-033750 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2018
    Labeler - Registered Chemicals Corporation (046652831)
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