drug facts

drug facts
SPL v6
SPL
SPL Set ID 968c0f18-d0b6-4f29-b001-00ac314a3bdd
Route
topical
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (5 mg)
Inactive Ingredients
water cocamine oxide hexylene glycol polyethylene glycol 8000 glycerin cocamidopropyl propylene glycol-dimonium chloride phosphate phenoxyethanol polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) myristic diisopropanolamide myristamine oxide anhydrous citric acid methyl gluceth-20 glyceryl mono- and dicaprylocaprate alcohol peg-12 dimethicone potassium citrate fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-08-12

Purpose

Antiseptic handwash

Description

Benzalkonium chloride 0.5%


Medication Information

Uses
  • For handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Directions
  • wet hands and apply foam
  • scrub hands and forearms
  • rinsethoroughly and dry
Other Information
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call (833) 571-1403
Description

Benzalkonium chloride 0.5%

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,  phenoxyethanol, polyquaternium 7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/carate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, blue 1

Section 53413-1

Questions? call 1-800-532-7732

Warning
For external use only
Do Not Use
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

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 Doctor If
  • skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Container

REORDER# 644084

1111218   778366   778366/7300/0521

FIRST MARK

ULTRA FOAMING ANTIBACTERIAL

HAND SOAP

Active Ingredient: Benzalkonium Chloride 0.5%

NDC 51042-001-10

Made in the USA

DISTRIBUTED BY:

PERFORMANCE FOOD GROUP

12500 WEST CREEK PARKWAY

RICHMOND VIRGINIA 23238


Structured Label Content

Uses
  • For handwashing to decrease bacteria on the skin
Purpose

Antiseptic handwash

Directions
  • wet hands and apply foam
  • scrub hands and forearms
  • rinsethoroughly and dry
Other Information (Other information)
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call (833) 571-1403
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,  phenoxyethanol, polyquaternium 7, myristamide DIPA, myristamine oxide, citric acid, methyl gluceth-20, glyceryl caprylate/carate, alcohol, PEG-12 dimethicone, potassium citrate, fragrance, blue 1

Section 53413-1 (53413-1)

Questions? call 1-800-532-7732

Warning
For external use only
Do Not Use (Do not use)
  • in eyes
Active Ingredient

Benzalkonium chloride 0.5%

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 Doctor If (Stop use and ask a doctor if)
  • skin irritation or redness occurs for more than 72 hours
Principal Display Panel and Representative Container (Principal display panel and representative container)

REORDER# 644084

1111218   778366   778366/7300/0521

FIRST MARK

ULTRA FOAMING ANTIBACTERIAL

HAND SOAP

Active Ingredient: Benzalkonium Chloride 0.5%

NDC 51042-001-10

Made in the USA

DISTRIBUTED BY:

PERFORMANCE FOOD GROUP

12500 WEST CREEK PARKWAY

RICHMOND VIRGINIA 23238


Advanced Ingredient Data


Raw Label Data

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