Label: DOP HAND SANITIZER- alcohol gel

  • NDC Code(s): 51048-027-04, 51048-027-08
  • Packager: Omega & Delta Co
  • 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 October 6, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 65%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses: For handwashing to decrease bacteria on the skin.

  • Warnings:

    For external use only

    Flammable. Keep away from heat and flame.

    When using this product keep out of eye.  In case of contact with eyes, flush thoroughly with water.  Avoid contact with broken skin.

    Stop use and ask a doctor if skin irritation develops.

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

  • DOSAGE & ADMINISTRATION

    Directions:  Wet hands thoroughly with product and allow to dry without wiping.  Use only under adult supervision.  Not recommended for infants.

  • OTHER SAFETY INFORMATION

    Other Information:  Do not store above 105o F.  May discolor some fabrics.  Harmful to wood finishes and plastics.

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Water, Glycerin, propylene Glycol, carbomer, Fragrance, and Triethanolamine

  • SPL UNCLASSIFIED SECTION

    Hecho en Puerto Rico por:

    Omega & Delta Co., Inc.P.O. Box 1449, Carolina, P.R. 00984

  • PRINCIPAL DISPLAY PANEL

    DOP

    Instant

    Hand

    Sanitizer

    with

    Moisturizers

    Original

    KILLS 99.9% of GERMS

    8 FL. OZ. (237 ml)DOP Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    DOP HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51048-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51048-027-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/09/2009
    2NDC:51048-027-08273 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/09/2009
    Labeler - Omega & Delta Co (090317793)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omega & Delta090317793manufacture(51048-027)
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