Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 86dfc5b3-768a-4d7b-9911-6a3f0cb00413
Route
TOPICAL
Published
Effective Date 2021-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (130 mg)
Inactive Ingredients
Water Lauramidopropylamine Oxide Glycerin Cetrimonium Chloride Sodium Chloride Coco Monoethanolamide Peg-120 Methyl Glucose Dioleate Fragrance Clean Orc0600327 Citric Acid Monohydrate Edetate Sodium Sodium Sulfate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Red No. 40 Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-07-13
Description

Benzalkonium Chloride (0.13%)

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride (0.13%)

Uses

Helps eliminate bacteria on hands

Pdp04

Warnings

For external use only 

Directions
  • use to refill a hand soap pump bottle.
  • From pump bottle, apply onto wet hands.
  • Lather and rinse thoroughly.
Other Information

Store at room temperature

Active Ingredient.

Benzalkonium Chloride (0.13%)

Inactive Ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Questions Or Comments ?

1-800-925-4733

When Using This Product

Avoid contact with eyes. In case of contact, rinse thoroughly with water. 

Stop Use and Ask A Doctor.

If irritation or redness develops and lasts

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses

Helps eliminate bacteria on hands

Pdp04 (PDP04)

Purpose

Antibacterial

Warnings

For external use only 

Directions
  • use to refill a hand soap pump bottle.
  • From pump bottle, apply onto wet hands.
  • Lather and rinse thoroughly.
Other Information

Store at room temperature

Active Ingredient.

Benzalkonium Chloride (0.13%)

Inactive Ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (Cl 17200).

Questions Or Comments ? (Questions or comments ?)

1-800-925-4733

When Using This Product (When using this product)

Avoid contact with eyes. In case of contact, rinse thoroughly with water. 

Stop Use and Ask A Doctor. (Stop use and ask a doctor.)

If irritation or redness develops and lasts

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:38.841147 · Updated: 2026-03-14T22:59:43.649746