Label: DRP HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 July 7, 2020

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  • DRUG FACTS

  • Active ingredients

    Ethyl alcohol 70%

  • Purpose

    Antiseptic Alcohol

  • INDICATIONS & USAGE

    Use For handwashing to decrease bacteria on skin. Only when water is not available.

  • WARNINGS

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

    When using this product Keep out of eyes. In case of contact, rinse eyes with water. Avoid contact with broken skin. Do not ingest or inhale.

    Stop use and ask a doctor if Irritation or redness develop.

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

  • DOSAGE & ADMINISTRATION

    Directions Rub hands thoroughly with product. Allow to dry without whiping, for children under 6, use only with adult supervision.

  • STORAGE AND HANDLING

    Other information Do not store above 105°F. May discolor fabrics. Harmful to wood finishes and plastics.

  • INACTIVE INGREDIENT

    Inactive ingredients Water, glycerin, preservative, carbomer, triethanolamine, fragrance, D&C Violet #2

  • SPL UNCLASSIFIED SECTION

    Green Apple

    70% alcohol

    Made in Mexico by

    Europremier S.A. de C.V.

    108 Cerezos St., Santa María

    Totoltepec, 50200, Toluca,

    Mexico

    +52 722 199 4990

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    DRP HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79202-001
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79202-001-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    2NDC:79202-001-221000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    3NDC:79202-001-333785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - Europremier, S.A. de C.V. (951579107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Europremier, S.A. de C.V.951579107manufacture(79202-001)
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