Label: ANTIMICROBIAL ALCOHOL HAND 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 December 27, 2017

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  • Antimicrobial Alcohol Gel Hand wipes

  • Active ingredient

    Alcohol 65.9% by volume

  • Purpose

    Antiseptic

  • Uses

    • Antiseptic.
    • For hand washing to decrease bacteria on the skin; after assisting ill persons; and before contact with a person under medical care or treatment.
    • Apply topically to the skin to help prevent cross-contamination
    • Recommended for repeated use.
    • Dries in seconds.
  • Warnings

    • Flammable, keep away from fire or flame
    • For external use only

    • Do not use

    in or contact the eyes

    • Discontinue use

    if irritation and redness develop，If condition persists for more than 72 hours consult a physician

    • Keep this out of reach of children

    unless under adult supervision • If swallowed, get medical help or contact a Poison Center immediately.

  • Directions

    • To start feed: Remove cover and discard seal from container, From center of toweled roll , pull up wipe corner; tear off fist wipe for use. Twist next wipe into a point and thread through the hole in the container cover.Pull through about one inch. Replace cover,Pull out wipes as needed and snap off at 90°angle. Keep cap closed to prevent moisture loss.
    • Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface. Allow to dry.
    • If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe, Sanitize with a second wipe.
    • Discard after single use.
  • Other information

    Lot No.and Expiration Date can be found on canister.

  • Inactive ingredients

    Water, Propylene Glycol, Glycerin, Carbormer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Tetrasodium EDTA

  • Package Label

    GeriGental

    Antimicrobial Alcohol Gel

    HAND WIPES

    Cleans and Moisturizes


    An antiseptic handwash to help

    prevent cross-contamination

    • Kills 99.99% of germs
    • Contains moisturizing aloe, glycerin and vitamin E
    • Removes soil and bacteria more effectively than gels alone

    135 Wipes 6x7.5 in (15x19cm)

    Label

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL ALCOHOL HAND WIPES 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69558-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69558-001-35135 in 1 CANISTER08/03/2016
    13.37 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/03/2016
    Labeler - GERI GENTILE CORP (361663839)
    Registrant - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
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