EVOWELLTM Hand Sanitizer

Evowell Hand Sanitizer by

Drug Labeling and Warnings

Evowell Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cemi International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EVOWELL HAND SANITIZER- benzalkonium chloride spray 
Cemi International, Inc

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.

----------

EVOWELLTM Hand Sanitizer

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antimicrobial and First Aid Antiseptic

Uses

  • hand sanitizer 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

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

  • wet hands thoroughly with product and allow to dry without wiping Directions
  • 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 use if the cap is broken
  • flammable, keep away from fire/flame

Inactive ingredients urea, water

Questions? 973-575-6591
You may also report serious side effects to this phone number. Mon-Fri 9:00 AM- 5:00 PM

WELLNESS EVOLVED

EXTENDED PROTECTION*

alcohol-free triclosan-free & fragrance-free

Non-Irritating Non-Stinging

*Studies show Benzalkonium Chloride protects against infection for more than three hours.


Made in the U.S.A.

BAC-D®

Antimicrobial & Antiseptic

Distributed by: EvoWell™ 10 Henderson Drive,
West Caldwell, NJ 07006
©Copyright EvoWell™ All rights reserved.

amazon.com N11873 310L0800601

Packaging

image description

EVOWELL HAND SANITIZER 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73741-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
UREA (UNII: 8W8T17847W)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73741-109-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/18/202004/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/202004/07/2022
Labeler - Cemi International, Inc (015038336)
Establishment
NameAddressID/FEIBusiness Operations
Cemi International, Inc015038336pack(73741-109)

Revised: 6/2023
Document Id: 9694b831-98b2-4efb-b7c5-cf21805f6240
Set id: b8c8fc79-aa52-4fa0-8ae8-18b64501e825
Version: 2
Effective Time: 20230622