Mystic

Manufacturer
Kay Chemical Company
Effective date
2024-08-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:56:15

Label at a glance#

ProductMystic
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63146-304MYSTIC (BENZALKONIUM CHLORIDE) SOLUTION [KAY CHEMICAL COMPANY]5Legacy NDC20240822_29d05188-581a-484c-88a9-84aa9bbfbb93.zip

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
63146-30463146-304-03, 63146-304-10

Ingredients#

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

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

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
f7351f57-aa94-4d48-9258-431c2901fad029d05188-581a-484c-88a9-84aa9bbfbb932025-12-31WarningsExact identifier
spl set id: 29d05188-581a-484c-88a9-84aa9bbfbb93

Reported adverse events (FAERS/openFDA)#

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