Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a126c273-4115-435c-86ce-4132b93ad576
Route
TOPICAL
Published
Effective Date 2018-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cetrimonium Chloride Glycerin Lauramidopropylamine Oxide Sodium Chloride Coco Monoethanolamide Peg-120 Methyl Glucose Dioleate Citric Acid Monohydrate Edetate Sodium Sodium Sulfate Citrus Nobilis Green Tea Leaf Ginger Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-09-12
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

helps eliminate bacteria on hands.

Directions
  • Use to refill a pump bottle. From pump bottle, apply onto wet hands.
  • Lather and rinse thoroughly.
Label Copy

  Warnings

For external use only

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • store at room temperature
Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camelilla Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

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.

Purpose

Antibacterial

Directions
  • Use to refill a pump bottle. From pump bottle, apply onto wet hands.
  • Lather and rinse thoroughly.
Label Copy

  Warnings

For external use only

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camelilla Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

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 If (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: 2026-02-15T11:56:38.666434 · Updated: 2026-03-14T22:55:14.803903