ASEPTOMED® ANTISEPTIC WET WIPES

ASEPTOMED ANTISEPTIC WET WIPES by

Drug Labeling and Warnings

ASEPTOMED 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]

ASEPTOMED ANTISEPTIC WET WIPES- ethyl alcohol 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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ASEPTOMED® ANTISEPTIC WET WIPES

Drug Facts

Active ingredient

Ethyl alcohol 75 % v/v

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

Flammable, keep away from fire/flame

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

denatonium benzoate, fragrance, isopropanol, methyl ethyl ketone, water

Questions? 

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

75% ETHYL ALCOHOL

Manufactured by: 

ULTRA COSMETICS SHPK,

Vitomirica pn, Peje,

Kosovo, 30000

COUNTRY OF ORIGIN: KOSOVO

ASEPTOMED ANTISEPTIC WET WIPES 75% ALCOHOL, disinfects hands and can reduce the danger of contact infections through hands.

For best results use at least 2 wipes.

Avoid Sunlight

Packaging

IMAGE

ASEPTOMED ANTISEPTIC WET WIPES 
ethyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80764-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYL ETHYL KETONE (UNII: 6PT9KLV9IO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80764-101-8080 in 1 CANISTER01/02/202012/09/2021
11.02 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/02/202012/09/2021
Labeler - ULTRA COSMETICS SH.P.K. (360370460)
Establishment
NameAddressID/FEIBusiness Operations
ULTRA COSMETICS SH.P.K.360370460manufacture(80764-101)

Revised: 12/2021
Document Id: 12e50718-1f6c-423d-9bad-97ef052d1679
Set id: 956fbe52-9d75-489e-b938-23d4f1724d51
Version: 2
Effective Time: 20211209