MOLCHEM HAND PURIFIER- benzalkonium chloride spray 
MOL BELTING SYSTEMS, 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.

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Warnings

For external use only.

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly
with water.

Stop use and ask a doctor if irritation or rash occurs. This may be a sign of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Other information

Store in dry place between 35° and 103°F

Directions

• Place enough product on hands to cover all surfaces. Rub hands together.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Uses

• To decrease bacteria on the skin.

• Recommended for repeated use.

• For use when soap and water are not available

Inactive ingredients

Deionized Water, Propylene glycol, Triethylene glycol, Phospholipids Complex, Organo Silane Quaternaries

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Product label

image description

MOLCHEM HAND PURIFIER 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80606-001
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
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80606-001-0159.14 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/15/2021
2NDC:80606-001-02236.58 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/15/2021
3NDC:80606-001-033785.41 mL in 1 DRUM; Type 0: Not a Combination Product07/15/2021
4NDC:80606-001-0418927.1 mL in 1 DRUM; Type 0: Not a Combination Product07/15/2021
5NDC:80606-001-05208198 mL in 1 DRUM; Type 0: Not a Combination Product07/15/2021
6NDC:80606-001-061040987.75 mL in 1 JUG; Type 0: Not a Combination Product07/15/2021
7NDC:80606-001-07500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/15/2021
Labeler - MOL BELTING SYSTEMS, INC (147753685)
Establishment
NameAddressID/FEIBusiness Operations
Mol Belting Systems Inc147753685pack(80606-001)

Revised: 6/2023
Document Id: fdb47d2c-56bd-4a7a-e053-6294a90a32e6
Set id: 303b5ce9-9715-4291-a899-649d1d70fc95
Version: 3
Effective Time: 20230609
 
MOL BELTING SYSTEMS, INC