CLEAN31- benzalkonium chloride liquid

Clean31 by

Drug Labeling and Warnings

Clean31 by is a Otc medication manufactured, distributed, or labeled by S3 Surface Solutions, LLC, Polyventive LLC, Guide Energy Solutions, Emerald 66 Enterprises LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Skin Anticeptic

Uses

For hand and skin sanitizing to decrease microbes on skin

Warnings

For external use only. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention

Stop use and ask a doctor

If irritation or redness develops, or if 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

Dispense an adequate amount in palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.

Other Information

Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed.

Inactive Ingredients

Water, Colloidal Silicon Dioxide

Questions?

email info@S3Surfaces.com

Alcohol-Free Formulation

S3 Surface Protect, Quality branded Clean31 Protection, Hand Sanitizer, Sanitizes, Protects up to 4 hours, Alcohol-Free, Fragrance-free, Up to 4 hours of Protection, Kills over 99.9% of Germs

Hand Sanitizer Label

Product label picture

INGREDIENTS AND APPEARANCE

CLEAN31 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81300-100
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
WATER (UNII: 059QF0KO0R)	99.67 g  in 100 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.2 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81300-100-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/08/2020
2	NDC: 81300-100-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2020
3	NDC: 81300-100-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2020
4	NDC: 81300-100-04	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/08/2020
5	NDC: 81300-100-05	3785.41 mL in 1 JUG; Type 0: Not a Combination Product	12/08/2020
6	NDC: 81300-100-06	18927.1 mL in 1 PAIL; Type 0: Not a Combination Product	12/08/2020
7	NDC: 81300-100-07	208198 mL in 1 DRUM; Type 0: Not a Combination Product	12/08/2020
8	NDC: 81300-100-08	1249000 mL in 1 CONTAINER; Type 0: Not a Combination Product	12/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/08/2020

Labeler - S3 Surface Solutions, LLC (087784389)

Registrant - S3 Surface Solutions, LLC (087784389)

Establishment
Name	Address	ID/FEI	Business Operations
Polyventive LLC		116722770	manufacture(81300-100)

Establishment
Name	Address	ID/FEI	Business Operations
Guide Energy Solutions		117045830	manufacture(81300-100)

Establishment
Name	Address	ID/FEI	Business Operations
Emerald 66 Enterprises LLC		117386196	manufacture(81300-100)