FDA.reportPublic FDA data

MYSTIC FOAMING ANTI-BACTERIAL HANDSOAP

Manufacturer
Ecolab Inc.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:30:16

Label at a glance#

ProductMYSTIC FOAMING ANTI-BACTERIAL HANDSOAP
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

for handwashing to decrease bacteria on the skin

Dosage and administration

Wet hands and apply foam Scrub hands and forearms Rinse thoroughly and dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic handwash

Uses

INDICATIONS & USAGE SECTION

  • for handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

  • For external use only

Do not use

OTC - DO NOT USE SECTION

  • in eyes

When using the product

OTC - WHEN USING SECTION

  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop

Stop use and ask a docotr if

OTC - ASK DOCTOR SECTION

  • Skin irritation or redness occurs 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 a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands and apply foam
  • Scrub hands and forearms
  • Rinse thoroughly and dry

Other information

REFERENCES SECTION

  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: In the USA and Canada, call 1-800-328-0026

INACTIVE INGREDIENT SECTION

Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, caprylic/capric glycerides, PEG-12 dimethicone, potassium hydroxide, fragrance, FD&C blue 1

OTC - QUESTIONS SECTION

Questions? Call 1-800-532-7732

Representative Label and Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63146-304-10

MYSTIC™

Foaming Anti-Bacterial Hand Soap

Active Ingredient: Benzalkonium chloride 0.5%

1110489

Net Content: 1250 mL (42.3 US FL OZ)

Distributed by:

SSDC Division, Kay Chemical Company

4050 Corporate Drive, #100

Grapevine, Texas 76051, USA 800.532.7732

©2022 Kay Chemical Company All Rights Reserved

765697/7301/0322

Representative labelRepresentative label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapPSN1
1731737benzalkonium chloride 5 MG/ML Medicated Liquid SoapSCD1
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-681-41MYSTIC FOAMING ANTI-BACTERIAL HANDSOAP750 mL in 1 BOTTLE, PLASTICSOLUTION7501
47593-681-59MYSTIC FOAMING ANTI-BACTERIAL HANDSOAP1250 mL in 1 BOTTLE, PLASTICSOLUTION12501

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47593-68147593-681-41, 47593-681-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
GLYCERYL MONO- AND DICAPRYLOCAPRATEU72Q2I8C85IACT
METHYL GLUCETH-20J3QD0LD11PIACT
MYRISTIC DIISOPROPANOLAMIDE17DN142CTKIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MYRISTAMINE OXIDEJ086PM3RRTIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
WATER059QF0KO0RIACT
COCAMINE OXIDEQWA2IZI6FIIACT

Source Document#

Source XML

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
MYSTIC FOAMING ANTI-BACTERIAL HANDSOAPBENZALKONIUM CHLORIDEEcolab Inc.5fe2b669-6a7a-49a5-8374-ad6298944e5c2025-12-31WarningsExact identifier
ndc (package): 47593-681-59
ndc (package): 47593-681-41
ndc (product): 47593-681
ndc11 (package): 47593068159
ndc11 (package): 47593068141
spl id: abe0f129-e0c9-4b23-8985-9a3144b88f49
spl set id: 5fe2b669-6a7a-49a5-8374-ad6298944e5c

Reported adverse events (FAERS/openFDA)#

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