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
Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Medication Information

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.

Purpose

Antimicrobial

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.

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.

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

Active Ingredient(s)  

Benzalkonium Chloride 0.13%

Structured Label Content

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.

Purpose

Antimicrobial

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.

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.

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

Active Ingredient(s)  

Benzalkonium Chloride 0.13%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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