FDA.reportPublic FDA data

Soothion Antiseptic Hand Sanitizer

Manufacturer
Electrolyzed Innovations, LLC | TropiChem Research Labs, Inc.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:35

Label at a glance#

ProductSoothion Antiseptic Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping.

Storage and handling

Store in a cool, dry place below 77°F Protect from heat and light

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping.

Other information

STORAGE AND HANDLING SECTION

  • Store in a cool, dry place below 77°F
  • Protect from heat and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

DESCRIPTION SECTION

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

PACKAGE LABEL.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)

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046442benzalkonium chloride 0.13 % Topical LotionPSN3
1046442benzalkonium chloride 1.3 MG/ML Topical LotionSCD3
1046442benzalkonium chloride 0.13 % Topical LotionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69031-006-082022-01-28C16284748780-1d6a99b39-9976-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69031-006-08Soothion Antiseptic Hand Sanitizer226 g in 1 BOTTLELOTION2263

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69031-006SOOTHION ANTISEPTIC HAND SANITIZER (BENZALKONIUM CHLROIDE) LOTION [ELECTROLYZED INNOVATIONS, LLC]3Legacy NDC, 1 package rows20201203_fe3a9d38-937f-4a07-b230-87439c5db1d6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6W1
THYMOLINACTIVE INGREDIENT3J50XA376E1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69031-00669031-006-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
THYME OIL2UK410MY6BIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYACRYLIC ACID (250000 MW)POLYACRYLIC ACID (250000 MW)9G2MAD7J6WFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
2 equally ranked IID candidates
THYMOLTHYMOL3J50XA376EPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
POLYACRYLIC ACID (250000 MW)POLYACRYLIC ACID (250000 MW)9G2MAD7J6WSYSTEM / TOPICAL196 mgExact identifier — unii candidate
2 equally ranked IID candidates
THYMOLTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b5825204-ce28-1392-e053-2995a90a135cfe3a9d38-937f-4a07-b230-87439c5db1d62020-12-02WarningsExact identifier
spl id: b5825204-ce28-1392-e053-2995a90a135c
spl set id: fe3a9d38-937f-4a07-b230-87439c5db1d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.