CLINICARE PRO SURFACE SANITIZER- benzalkonium chloride, didecyl dimethyl ammonium chloride liquid 
Meroven 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.

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Clinicare Pro Surface Sanitizer

Drug Facts

Active ingredient

▪ Benzalkonium Chloride 0.13%

▪ Didecyl dimethyl ammonium chloride 0.15%

Purpose

Antiseptic

Uses ▪ surface sanitizer to decrease germs

        ▪ recommended for repeated use

        ▪ for use when soap and water are not available

Warnings

For surface use only

Do not use  ▪  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 surface thoroughly with product and allow to dry without wiping

Other information  ▪ store between 15-30°C (59-86°F)

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

Inactive ingredients  ▪ Propylene glycol (plasticizer) ▪ Laureth-4 (Surfactant) ▪ Water ▪ Glycolic acid ▪ 1-Octadecanaminium NN dimethyl (3-trihydroxysily) propyl chloride ▪ Dimethyloctadecyl (3-trimethoxysilyl) Propyl Ammonium Chloride

Questions? +1-312-803-1738

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

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

EXTEN-DAY

24 HOUR

Up to 24 hours continuous protection

Kills 99.99% of germs*

Bonds to most surfaces

Fast Acting 15 Second Formula

*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little

as 15 seconds; it forms a non-toxic barrier with lasting effects for up to 24 hours and does not produce

the harmful, dermatological effects associated with traditional, high alcohol based hand sanitizers

Manufactured for: Meroven LLC - 7901 4th St. N STE 300,St.

Petersburg, FL., 33702

Country of origin: Spain

Packaging

image description

CLINICARE PRO SURFACE SANITIZER 
benzalkonium chloride, didecyl dimethyl ammonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74653-104
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
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LAURETH-4 (UNII: 6HQ855798J)  
WATER (UNII: 059QF0KO0R)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)  
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74653-104-2180 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
2NDC:74653-104-22500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
3NDC:74653-104-231000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
4NDC:74653-104-243000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
5NDC:74653-104-255000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2020
Labeler - Meroven LLC (117473235)

Revised: 6/2020
Document Id: f7e68a18-7287-4a1c-810a-23e1da45a12c
Set id: d61cb861-ff0a-4ba7-a3e6-6d20424feff2
Version: 1
Effective Time: 20200623
 
Meroven LLC