AMERICAN INFECTION CONTROL ANTISEPTIC BODY WIPES- alcohol cloth

American Infection Control Antiseptic Body Wipes by

Drug Labeling and Warnings

American Infection Control Antiseptic Body Wipes by is a Otc medication manufactured, distributed, or labeled by American Infection Control, Inc., Sapro Temizlik Urunleri Sanayi ve Ticaret A.S.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

Ethyl Alcohol 62% (v/v)

Purpose

Antiseptic

Uses:

For cleansing of exposed areas of the body to decrease bacteria on the skin after assisting ill persons or after athletic competition involving direct skin contact, or swimming / bathing in water that has not been pre-treated for bacterial contamination, or any other activity where exposure of the skin to germs may be of concern. 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:

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:

Aloe Barbadensis Extract, Propylene Glycol, Purified Water.

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Case Label

A I C AMERICAN INFECTION CONTROL™

ANTISEPTIC BODY WIPES
65 wipes per canister / 12 units per case

Made in Turkey for:
American Infection Control, Inc.
23950 Commerce Park
Beachwood, Ohio 44122
(216) 342-4660

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Canister Label

A I C AMERCIAN INFECTION CONTROL

ANTISEPTIC
BODY WIPES
Kills Over 99.99% of Harmful Germs & Bacteria

WON'T DRY SKIN FRAGRANCE FREE EMOLLIENT RICH
WITH REPEATED USE MOISTURIZING FORMULA

65 PRE-MOISTENED WIPES (8 in. x 14 in.)

INGREDIENTS AND APPEARANCE

AMERICAN INFECTION CONTROL ANTISEPTIC BODY WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76113-112
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: 76113-112-23	12 in 1 CASE
1		494 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(76113-112) , ANALYSIS(76113-112)