Antiseptic Wipe by GFL SA Antiseptic Wipe

Drug Details [pdf]

ANTISEPTIC WIPE- alcohol cloth
GFL SA

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.

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Antiseptic Wipe

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Use

for hand washing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use

in the eyes

Stop use and ask a doctor if

irritation and redness develop
condition 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

wipe hands thoroughly with product and allow to dry.

Other information

Store between 59-86°F (15-30°C)
Avoid freezing and excessive heat above 104°F (40°C)

Inactive ingredients

Water (aqua), glycerin.

Package Labeling:

Label

ANTISEPTIC WIPE
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77513-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 77513-003-01	1 in 1 BAG	07/27/2020	10/07/2023
1		6 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/27/2020	10/07/2023

Labeler - GFL SA (486270809)

Revised: 10/2021

Document Id: cdafd673-d6af-17e7-e053-2995a90a51b9

Set id: a1ff802f-9990-412b-9bc3-5666e1fc06bc

Version: 2

Effective Time: 20211006