Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e7f7395e-7ad8-47ec-9f55-0ad868f861b5
Route
TOPICAL
Published
Effective Date 2019-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cetrimonium Chloride Lauramidopropylamine Oxide Glycerin Lauramine Oxide Sodium Chloride Coco Monoethanolamide Peg-120 Methyl Glucose Dioleate Citric Acid Monohydrate Edetate Sodium Sodium Benzoate Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-07-18
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

helps eliminate bacteria on hands.

Warnings

For external use only.

Directions
  • apply onto wet hands.
  • lather and rinse thoroughly.
Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information 

store at room temperature.

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Lauramine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Benzoate, Blue 1 (CI 42090), Red 33 (CI 17200).

When Using This Product
  • avoid contact with eyes. In case of contact, rinse thoroughly with water.
Sto 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.

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • apply onto wet hands.
  • lather and rinse thoroughly.
Label Copy (Label copy)

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information  (Other information )

store at room temperature.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Lauramine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Benzoate, Blue 1 (CI 42090), Red 33 (CI 17200).

When Using This Product (When using this product)
  • avoid contact with eyes. In case of contact, rinse thoroughly with water.
Sto Use and Ask A Doctor If (Sto 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: 2026-02-15T11:56:50.335121 · Updated: 2026-03-14T22:55:35.679907