ANTISEPTIC WIPE- alcohol cloth

Antiseptic Wipe by

Drug Labeling and Warnings

Antiseptic Wipe by is a Otc medication manufactured, distributed, or labeled by DJO LLC, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

• for handwashing to decrease bacteria on skin whenever soap and water is not readily available
• helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection

Warnings

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

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop use and ask a doctor if

• irritation or redness develop and persists for more than 72 hours

Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away

Directions

• unsnap entire canister cap and thread towelette through pre-cut slot
• pull towelette out of cap slot at an angle to dispense
• wet hands and wrists thoroughly with wipe for 15 seconds and allow to air dry
• dispose of used towelette properly
• always reseal after use
• children under 6 years of age should be supervised when using this product

Inactive ingredients

aloe vera, fragrance, purified water, triethanolamine

Principal Display Panel - 160 Wipes Canister Label

HAND WIPES

GERM
WAR®

KILLS 99.99%
OF GERMS

WAGING WAR
ON GERMS
AND BACTERIA

160 WIPES (5IN X 8IN)

INGREDIENTS AND APPEARANCE

ANTISEPTIC WIPE 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80950-3111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)	alcohol	665 mL  in 100 L

Inactive Ingredients
Ingredient Name	Strength
aloe (UNII: V5VD430YW9)
water (UNII: 059QF0KO0R)
trolamine (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80950-3111-3	160 in 1 CANISTER	12/14/2020
1		0.00325 L in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/14/2020

Labeler - DJO LLC (081840873)

Registrant - Safetec of America, Inc. (874965262)