CLEAN31- benzalkonium chloride liquid 
S3 Surface Solutions, 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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Active Ingredients

Benzalkonium Chloride 0.13%

Clean 31

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

Clean31

CLEAN31 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81300-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 99.67 g  in 100 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.2 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81300-100-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/08/2020
2NDC:81300-100-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2020
3NDC:81300-100-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2020
4NDC:81300-100-041000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/08/2020
5NDC:81300-100-053785.41 mL in 1 JUG; Type 0: Not a Combination Product12/08/2020
6NDC:81300-100-0618927.1 mL in 1 PAIL; Type 0: Not a Combination Product12/08/2020
7NDC:81300-100-07208198 mL in 1 DRUM; Type 0: Not a Combination Product12/08/2020
8NDC:81300-100-081249000 mL in 1 CONTAINER; Type 0: Not a Combination Product12/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/08/2020
Labeler - S3 Surface Solutions, LLC (087784389)
Registrant - S3 Surface Solutions, LLC (087784389)
Establishment
NameAddressID/FEIBusiness Operations
Polyventive LLC116722770manufacture(81300-100)
Establishment
NameAddressID/FEIBusiness Operations
Guide Energy Solutions117045830manufacture(81300-100)
Establishment
NameAddressID/FEIBusiness Operations
Emerald 66 Enterprises LLC117386196manufacture(81300-100)

Revised: 1/2021
Document Id: b8520048-48da-192b-e053-2995a90ab5c7
Set id: b5f84376-1f92-ebe6-e053-2a95a90a821e
Version: 2
Effective Time: 20210107
 
S3 Surface Solutions, LLC