drug facts

drug facts
SPL v1
SPL
SPL Set ID f5dcb3ce-4620-4fba-be3a-3898726c236b
Route
topical
Published
Effective Date 2014-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (.56 g)
Inactive Ingredients
water sodium laureth-3 sulfate cocamidopropyl betaine glycerin dmdm hydantoin xanthan gum edetate disodium citric acid monohydrate fd&c red no. 4 d&c red no. 33 fd&c yellow no. 5 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2014-03-27
Description

Inactive Ingredients - Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, DMDM Hydantoin, Benalkonium Clhoride, Fragrance, Xanthan Gum, Disodium EDTA, Citiric Acid. May contain: CI 14700, CI 17200, CI 19140, Ci 42090

Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active Ingredient

Benzalkonium Chloride  0,2 %

Indications and Usage

Use - handwashing to decrease bacteria on skin

Dosage and Administration

Directions - wet hands, work into

rich lather - rinse well

Description

Inactive Ingredients - Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, DMDM Hydantoin, Benalkonium Clhoride, Fragrance, Xanthan Gum, Disodium EDTA, Citiric Acid. May contain: CI 14700, CI 17200, CI 19140, Ci 42090

Section 50565-1

EKeep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develop

Section 50567-7

When using this product, avoid contact with eyes. If contact occurs,

rinse thoroughly with water.

Section 51727-6

Inactive Ingredients - Water, Sodium Laureth

Sulfate, Cocamidopropyl Betaine, Glycerin, DMDM

Hydantoin, Benalkonium Clhoride, Fragrance,

Xanthan Gum, Disodium EDTA,

Citiric Acid. May contain: CI 14700, CI 17200, CI 19140, Ci 42090

Section 51945-4

Section 53413-1

Questions? 1-800-FDA-1088

Section 55105-1

Purpose

Antibacterial

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active Ingredient

Benzalkonium Chloride  0,2 %

Indications and Usage (34067-9)

Use - handwashing to decrease bacteria on skin

Dosage and Administration (34068-7)

Directions - wet hands, work into

rich lather - rinse well

Section 50565-1 (50565-1)

EKeep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop

Section 50567-7 (50567-7)

When using this product, avoid contact with eyes. If contact occurs,

rinse thoroughly with water.

Section 51727-6 (51727-6)

Inactive Ingredients - Water, Sodium Laureth

Sulfate, Cocamidopropyl Betaine, Glycerin, DMDM

Hydantoin, Benalkonium Clhoride, Fragrance,

Xanthan Gum, Disodium EDTA,

Citiric Acid. May contain: CI 14700, CI 17200, CI 19140, Ci 42090

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-FDA-1088

Section 55105-1 (55105-1)

Purpose

Antibacterial

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:46.452640 · Updated: 2026-03-14T22:53:43.600487