Label: AMERICAN INFECTION CONTROL ANTISEPTIC HAND WIPES- alcohol cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 76113-012-25 - Packager: American Infection Control, Inc.
- 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
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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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.
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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.
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Directions:
Remove lid and seal. Open cap. Thread center towelette through lid. Pull up straight to remove towelette. Wipe hands and wrists thoroughly. Close cap and dispose towelette appropriately. After first use continue to dispense towelettes until canister is empty.
FLAMMABLE. KEEP AWAY FROM HIGH HEAT OR DIRECT FLAME
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMERICAN INFECTION CONTROL ANTISEPTIC HAND WIPES
alcohol clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76113-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol .62 mL in 1 mL Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76113-012-25 12 in 1 CASE 1 385 mL in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/15/2012 Labeler - American Infection Control, Inc. (967579934) Establishment Name Address ID/FEI Business Operations Sapro Temizlik Urunleri Sanayi ve Ticaret A.S. 365536965 MANUFACTURE(76113-012) , ANALYSIS(76113-012)
