ULTRA CLEAN TOUCH ANTISEPTIC WET WIPES

ULTRA CLEAN TOUCH ANTISEPTIC WET WIPES by

Drug Labeling and Warnings

ULTRA CLEAN TOUCH ANTISEPTIC WET WIPES by is a Otc medication manufactured, distributed, or labeled by ULTRA COSMETICS SH.P.K.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRA CLEAN TOUCH ANTISEPTIC WET WIPES- benzalkonium chloride cloth 
ULTRA COSMETICS SH.P.K.

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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ULTRA CLEAN TOUCH ANTISEPTIC WET WIPES

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

hand wipes to decrease bacteria on the skin

recommended for repeated use

for use when soap and water are not available

Warnings

For external use only

Do not use
in children less than 2 months of age
on open skin wounds
as a baby wipe

When using this product  do not get into eyes. In case of contact, rinse eyes thoroughly with water

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 without wiping

supervise children under 6 years of age when using this product to avoid swallowing

Other information

store between 15-30°C (59-86°F)

avoid freezing and excessive heat above 40°C (104°F)

do not store near heat or open flame

Inactive ingredients

fragrance, glycerin, phenoxyethanol, sodium benzoate, water

Questions? 

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

REDUCE BACTERIA ON HANDS

ALCOHOL FREE

ULTRA CLEAN TOUCH ANTISEPTIC WET WIPES Alcohol Free, disinfects hands and can reduce the danger of contact infections through hands. For best results use at least 2 wipes.

Manufactured by:
ULTRA COSMETICS SHPK,
Vitomirica pn, Peje,
Kosovo, 30000

COUNTRY OF ORIGIN: KOSOVO

Packaging

ULTRA CLEAN TOUCH ANTISEPTIC WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80764-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80764-100-48	48 in 1 PACKET	10/01/2020	12/09/2021
1		4.1 mL in 1 PACKAGE; 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	10/01/2020	12/09/2021

Labeler - ULTRA COSMETICS SH.P.K. (360370460)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA COSMETICS SH.P.K.		360370460	manufacture(80764-100)

Revised: 12/2021

Document Id: 012ce81a-40d5-40c8-8e09-f6129ea808bb

34390-5

Set id: 598155b1-20cb-4d09-88e4-d6e08122148a

Version: 3

Effective Time: 20211209