Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 5fe2b669-6a7a-49a5-8374-ad6298944e5c
Route
TOPICAL
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (5 mg)
Inactive Ingredients
Fd&c Blue No. 1 Potassium Hydroxide Peg-12 Dimethicone (300 Cst) Glyceryl Mono- And Dicaprylocaprate Methyl Gluceth-20 Myristic Diisopropanolamide Anhydrous Citric Acid Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Phenoxyethanol Myristamine Oxide Cocamidopropyl Pg-dimonium Chloride Phosphate Glycerin Polyethylene Glycol 8000 Hexylene Glycol Water Cocamine Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-31

Description

Benzalkonium chloride 0.5%

Purpose

Antiseptic handwash


Medication Information

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.5%

Uses
  • for handwashing to decrease bacteria on the skin
Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

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

Section 53413-1

Questions? Call 1-800-532-7732

Warnings
  • For external use only
Directions
  • Wet hands and apply foam
  • Scrub hands and forearms
  • Rinse thoroughly and dry
Do Not Use
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: In the USA and Canada, call 1-800-328-0026
When Using the Product
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Stop Use and Ask A Docotr If
  • Skin irritation or redness occurs for more than 72 hours
Representative Label and 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


Structured Label Content

Uses
  • for handwashing to decrease bacteria on the skin
Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions? Call 1-800-532-7732

Purpose

Antiseptic handwash

Warnings
  • For external use only
Directions
  • Wet hands and apply foam
  • Scrub hands and forearms
  • Rinse thoroughly and dry
Do Not Use (Do not use)
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

Other Information (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • EMERGENCY HEALTH INFORMATION: In the USA and Canada, call 1-800-328-0026
When Using the Product (When using the product)
  • if in eyes, rinse promptly and thoroughly with water
  • discontinue use if irritation and redness develop
Stop Use and Ask A Docotr If (Stop use and ask a docotr if)
  • Skin irritation or redness occurs for more than 72 hours
Representative Label and 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


Advanced Ingredient Data


Raw Label Data

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