Label: ESCA HAND SANITIZING WIPES- alcohol 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 1, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                                      Purpose
    Ethyl Alcohol 65% by volume...................Antiseptic
  • INDICATIONS & USAGE

    Uses

    Instant hand sanitizer and antiseptic

    Handwash to help reduce bacteria that potentially can cause disease

    Recommended for repeated use

  • WARNINGS

    Warnings

    For external use only.

    Flammable - Keep away from fire or flame.

    Stop use and ask a doctor if irritation or redness develops.

    If condition persists for more than 72 hours, consult a doctor.

    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 wipe and allow to dry without wiping.

    If visibly soiled, remove visible soil and contamination first, discard first wipe, and use a second wipe to complete sanitizings.

    Discard wipe after single use.




  • SAFE HANDLING WARNING


    Other Information

    This is not a baby wipe!

    Remove lid from canister and discard seal from container.

    Lift flap in center of lid.

    Pull up corner of center wipe, twist to a point and thread through dispenser hole in lid.

    DO NOT PUSH FINGER THROUGH OPENING.

    Replace lid. Pull out exposed wipe and snap off. The next wipe pops out automatically.

    Dispose of used wipes in trash receptacle. Snap center flap down when finished to retain moisture.

    Do not flush.


  • INACTIVE INGREDIENT


    Inactive Ingredients

    water, isopropyl alcohol, glycerin, dimethicone, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL

    Part # SW-T160

    Contains Vitamin E

    ESCA Hand Sanitizing Wipes

    An Antiseptic hand wipe with 65% alcohol per CDC Recommendations

    Kills 99.9% of Germs on Contact

    Reduces Risk of Infection and Cross Contamination

    Friction of Wipe Helps Remove Bacteria and Dirt

    Gentle on Hands, Contains Moisturizers and Vitamin E

    160 wipes 6 x 6.75 IN. each (15.2 x 17.1 cm)

    containel label



  • INGREDIENTS AND APPEARANCE
    ESCA HAND SANITIZING WIPES 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52033-001
    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)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52033-001-01690 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/01/2010
    Labeler - ESCA Tech, Inc. (051144475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Multi Pack LLC123552122manufacture
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