Complete Lotion Hand Soap With 0.14% Benzalkonium Chloride

Complete Lotion Hand Soap With 0.14% Benzalkonium Chloride
SPL v1
SPL
SPL Set ID 41ed32ea-5a3b-fa50-e063-6394a90a20c4
Route
TOPICAL
Published
Effective Date 2025-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Lauramine Oxide Glycerin .alpha.-amylcinnamaldehyde Geraniol Water Butylphenyl Methylpropional Benzyl Salicylate Coumarin Fd&c Yellow No. 5 D&c Red No. 33 Anhydrous Citric Acid Linalool, (+/-)- Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-13

Description

Active ingredient Benzalkonium chloride 0.13%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

For handwashing to decrease bacteria on skin.

Dosage and Administration

Directions

Apply a small amount to wet hands, and rub lightly together to produce a rich lather. Rinse hands thoroughly with water, and dry skin with a clean towel.

Description

Active ingredient Benzalkonium chloride 0.13%

Section 42229-5

LOT

EXP:

Simoniz Saniclean, LLC

299 Dividend Road

Rocky Hill, CT 06067

1-800-227-5536

Section 50565-1

Keep out of reach of children.

If swallowed, drink a large quantity of water and seek medical help or contact a poison control center.

Section 50566-9

Stop use and ask a doctor if

Irritation or redness develops.



Section 50567-7

When using this product

  • Avoid contact with eyes.
  • In case of eye contact, flush with water for 15 minutes.

Section 50570-1

Do not use

On infants under 6 months of age.

Section 51727-6

Inactive ingredients

water; PEG-7 glyceryl cocoate; lauramine oxide; glycerin; fragrance (linalool, (+/-)-; .alpha.-amylcinnamaldehyde; butylphenyl methylpropional; geraniol; coumarin; benzyl salicylate); anhydrous citric acid; edetate disodium; FD&C yellow no. 5; D&C red no. 33

Section 51945-4

SaniClean

SIMONIZ

HAND CARE

Complete

Lotion Hand Soap

with

Benzalkonium Chloride

NET CONTENTS: 1 U.S. gallon (378 l)

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredient

Benzalkonium chloride 0.13%

Other Information

  • Store at room temperature.
  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients




Structured Label Content

Indications and Usage (34067-9)

Uses

For handwashing to decrease bacteria on skin.

Dosage and Administration (34068-7)

Directions

Apply a small amount to wet hands, and rub lightly together to produce a rich lather. Rinse hands thoroughly with water, and dry skin with a clean towel.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

LOT

EXP:

Simoniz Saniclean, LLC

299 Dividend Road

Rocky Hill, CT 06067

1-800-227-5536

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, drink a large quantity of water and seek medical help or contact a poison control center.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

Irritation or redness develops.



Section 50567-7 (50567-7)

When using this product

  • Avoid contact with eyes.
  • In case of eye contact, flush with water for 15 minutes.

Section 50570-1 (50570-1)

Do not use

On infants under 6 months of age.

Section 51727-6 (51727-6)

Inactive ingredients

water; PEG-7 glyceryl cocoate; lauramine oxide; glycerin; fragrance (linalool, (+/-)-; .alpha.-amylcinnamaldehyde; butylphenyl methylpropional; geraniol; coumarin; benzyl salicylate); anhydrous citric acid; edetate disodium; FD&C yellow no. 5; D&C red no. 33

Section 51945-4 (51945-4)

SaniClean

SIMONIZ

HAND CARE

Complete

Lotion Hand Soap

with

Benzalkonium Chloride

NET CONTENTS: 1 U.S. gallon (378 l)

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium chloride 0.13%

Other Information

  • Store at room temperature.
  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients




Advanced Ingredient Data


Raw Label Data

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