SOOTHION ANTISEPTIC HAND SANITIZER- benzalkonium chlroide lotion 
Electrolyzed Innovations, 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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Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

Warnings

For external use only.

When using this product

avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

  • irritation and redness develops
  • condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately. For children under 6, only use under adult supervision.

Directions

Other information


Inactive ingredients

Water, Calendula Oil, Fragrance Oil, Thyme Oil, Tea Tree Oil, Polyacrylic Acid

Questions? Call:

1-866-528-3721 ex. 210.



Mon-Fri 9AM to 5PM CST



Manufactured For

Electrolyzed Innovations, LLC
1747 Commerce Dr. P.O Box 1499

Piqua, OH 45356


Principal Display Panel

FDA NDC # 69031-006-08

Alcohol Free

Antiseptic Gel Hand Sanitizer

Soothion

Non Dyring Formula Will Leave Your Hands Soft and Smooth

Kills 99.9% of Common Germs

Ion Dispersion Technology

Enhanced with Quality Essential Oils

8 fl oz (236 mL)

PDP

SOOTHION ANTISEPTIC HAND SANITIZER 
benzalkonium chlroide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69031-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
THYME OIL (UNII: 2UK410MY6B)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69031-006-08226 g in 1 BOTTLE; Type 0: Not a Combination Product03/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2015
Labeler - Electrolyzed Innovations, LLC (079168827)
Establishment
NameAddressID/FEIBusiness Operations
TropiChem Research Labs, Inc.603123068manufacture(69031-006)

Revised: 12/2020
Document Id: b5825204-ce28-1392-e053-2995a90a135c
Set id: fe3a9d38-937f-4a07-b230-87439c5db1d6
Version: 3
Effective Time: 20201202
 
Electrolyzed Innovations, LLC