AMERICAN INFECTION CONTROL ANTISEPTIC HAND WIPES- alcohol cloth 
American Infection Control, Inc.

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 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.

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 – 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
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)

Revised: 2/2012
Document Id: f7f20fc3-e0d0-4954-ac59-208ea984d55f
Set id: 26c70482-499e-43e7-bf85-e4112e8b1bad
Version: 2
Effective Time: 20120206
 
American Infection Control, Inc.