Ultraclean

Ultraclean
SPL v1
SPL
SPL Set ID cb1247f1-56fd-4263-9ccc-23d5ecc9523a
Route
TOPICAL
Published
Effective Date 2020-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Cocamidopropyl Betaine Coco Glucoside Glycerin Peg-150 Distearate Coco Monoisopropanolamide Sodium Benzoate Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Edetate Disodium Anhydrous Lime Oil Phenoxyethanol Citric Acid Monohydrate .alpha.-tocopherol Acetate Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-31
Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Use(s)

For hand washing to help reduce bacteria and germs on the skin.

Section 42229-5

Section 50565-1

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

Warnings

• For external use only.

• Not edible, Don’t drink.

• Prolonged skin contact may cause temporary irritation.

Do not Use

• in children less than 2 months of age.

• on open skin wounds.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Direction

• Pump into hands, wet as needed.

• Lather vigorously for at least 15 seconds.

• Wash hands, rinse thoroughly and dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Packaging

Other Information

Store between 59-86ºF (15-30ºC). Avoid freezing and excessive heat above 104ºF (40ºC). May discolor certain fabrics and surfaces.

Inactive Ingredients

Aqua, Cocamidopropyl Betaine, Coco-Glucoside, Glycerin, Peg 150 Distearate, Cocomide MIPA,

Sodium Benzoate, Polyquaternium 7, Disodium EDTA, Lime Oil, Phenoxyethanol, Citric Acid,

Tocopheryl Acetate, Panthenol.

Active Ingredient(s)  

Benzalkonium Chloride 0.13%

Structured Label Content

Use(s)

For hand washing to help reduce bacteria and germs on the skin.

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)

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

Purpose

Antimicrobial

Warnings

• For external use only.

• Not edible, Don’t drink.

• Prolonged skin contact may cause temporary irritation.

Do not Use

• in children less than 2 months of age.

• on open skin wounds.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Direction

• Pump into hands, wet as needed.

• Lather vigorously for at least 15 seconds.

• Wash hands, rinse thoroughly and dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Packaging

Other Information

Store between 59-86ºF (15-30ºC). Avoid freezing and excessive heat above 104ºF (40ºC). May discolor certain fabrics and surfaces.

Inactive Ingredients

Aqua, Cocamidopropyl Betaine, Coco-Glucoside, Glycerin, Peg 150 Distearate, Cocomide MIPA,

Sodium Benzoate, Polyquaternium 7, Disodium EDTA, Lime Oil, Phenoxyethanol, Citric Acid,

Tocopheryl Acetate, Panthenol.

Active Ingredient(s)  

Benzalkonium Chloride 0.13%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:58:46.714365 · Updated: 2026-03-14T22:58:31.850591