Label: XEPI RUB ET HAND SANITIZING HANDRUB- ethyl alcohol solution

  • 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 December 28, 2020

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  • DRUG FACTS

  • Active ingredients

    Ethyl Alcohol 80.0% v/v

  • Purpose

    Antiseptic Handrub

  • Uses:

    * A hand rub to decrease microbial load on the skin

  • Warnings:

    * For external use only

    * Flammable. Keep away from fire or flame, heat sparks and sources of static discharge.

    When using this product:

    * Keep out of Eyes, Ears and Mouth.

    * In case of contact with eyes, rinse promptly & thoroughly with water.

    * Discontinue use if irritation and redness develop.

    Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    * Apply product onto hands, spread thoroughly & rub until dry.

  • Other information:

    * Store below 30°C

    * See Safety Data Sheet (SDS)

    * For emergency medical information in USA, call ..........................

  • Inactive ingredients:

    Hydrogen Peroxide 0.125% v/v, Water (aqua), Glycerin, Carbomer 940, Aminomethyl Propanol, Dettol Frag.

  • Questions or comments?

    * Call: +91 40 4221 2432 / 33

    * Email: info@sanmed.in

  • SPL UNCLASSIFIED SECTION

    World Health Organization Recommended Formulation

    Manufactured by:

    Sanmed Healthcare Pvt. Ltd.

    Plot No: 56, TSIIC, Biotech Park Phase-III

    Karakapatla - 502279. India.

  • Packaging

    Xepirub

  • INGREDIENTS AND APPEARANCE
    XEPI RUB ET HAND SANITIZING HANDRUB 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81357-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81357-101-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
    2NDC:81357-101-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
    3NDC:81357-101-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
    4NDC:81357-101-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
    5NDC:81357-101-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
    6NDC:81357-101-063785 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/28/2020
    Labeler - Sanmed Healthcare Private Limited (854248431)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanmed Healthcare Private Limited854248431manufacture(81357-101)
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