Label: AMERICAN INFECTION CONTROL ANTISEPTIC HAND WIPES- alcohol cloth

  • 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 February 6, 2012

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Ethyl Alcohol 62% (v/v)

  • Purpose

    Antiseptic

  • Uses:

    For handwashing to decrease bacteria on the skin after assisting ill persons, before contact with a person under medical care or treatment, or after changing diapers, and to remove light soil and germs from the skin. Not for use on intimate parts of the body, as the alcohol may sting or cause inflammation.

  • WARNINGS

    For external use only.

    • Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice.
    • Not for use on broken or irritated skin, unless recommended by a health care professional for wound or first aid cleansing.
    • Discontinue use and seek medical attention if skin irritation or redness develops.
  • Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

  • Directions:

    Snap open lid. Remove wipes for use. Wipe hands and wrists thoroughly, using more than one wipe if necessary. Snap lid closed between uses to preserve moisture and freshness of the product. When pack is empty dispose of the empty packaging materials properly or recycle with other plastic items. FLAMMABLE. KEEP AWAY FROM HIGH HEAT OR DIRECT FLAME

  • Inactive Ingredients:

    Aloe Barbadensis Extract, Propylene Glycol, Purified Water.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Package Label

    ANTISEPTIC HAND WIPES

    Kills Over WON'T
    99.99% DRY
    of Harmful HANDS
    Germs & WITH
    Bacteria REPEATED
    FRAGRANCE FREE USE

    80 PRE-MOISTENED WIPES (6 in. x 7 in.)

    Principal Display Panel – Package Label
  • INGREDIENTS AND APPEARANCE
    AMERICAN INFECTION CONTROL ANTISEPTIC HAND WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76113-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76113-012-5420 in 1 CASE
    1228 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/15/2012
    Labeler - American Infection Control, Inc. (967579934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sapro Temizlik Urunleri Sanayi ve Ticaret A.S.365536965MANUFACTURE(76113-012) , ANALYSIS(76113-012)