ANTISEPTIC WIPE- alcohol cloth

United States - English - NLM (National Library of Medicine)

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Active ingredient:
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M)
Available from:
DJO LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic - 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
Authorization status:
OTC monograph not final
Authorization number:
80950-3111-1

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ANTISEPTIC WIPE- alcohol cloth

DJO LLC

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 ingredients

Ethyl Alcohol 66.5%

Purpos e

Antiseptic

Us es

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 contact occurs, rinse eyes 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

tear open packet and remove towelette

wipe hand, finger and wrist areas thoroughly with towelette for 15 seconds

dispose of used towelette properly

children under 6 years of age should be supervised when using this product

Inactive ingredients

aloe vera, fragrance, purified water, triethanolamine

Principal Display Panel - 100 Wipes Box Label

HAND WIPES

GERM

WAR

KILLS 99.99%

®

OF GERMS

WAGING WAR

ON GERMS

AND BACTERIA

100 WIPES (5IN X 8IN)

Principal Display Panel - 1 Wipe Pouch Label

HAND WIPES

GERM

WAR

KILLS 99.99%

OF GERMS

WAGING WAR

ON GERMS

AND BACTERIA

1 WIPE

®

ANTISEPTIC WIPE

alcohol cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 0 9 50 -3111

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

a lco ho l (UNII: 3K9 9 58 V9 0 M) (alco ho l - UNII:3K9 9 58 V9 0 M)

a lc o ho l

6 6 5 mL in 10 0 L

Inactive Ingredients

Ingredient Name

Stre ng th

a lo e (UNII: V5VD430 YW9 )

wa ter (UNII: 0 59 QF0 KO0 R)

tro la mine (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 0 9 50 -3111-

10 0 in 1 BOX

12/14/20 20

1

1 in 1 PACKET

1

0 .0 0 17 L in 1 APPLICATOR; Type 0 : No t a Co mbinatio n

DJO LLC

1

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

12/14/20 20

Labeler -

DJO LLC (081840873)

Registrant -

Safetec of America, Inc. (874965262)

Revised: 6/2020

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