Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8e013c27-4b29-4508-ab8b-846356aae51a
Route
TOPICAL
Published
Effective Date 2018-01-12
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 2018-01-11
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

for washing to decrease bacteria on the skin.

Warnings

For external use only.

Labe Copy

Directions
  • use to refill a pump bottle.
  • from pump bottle, apply onto wet hands.
  • lather and rinse thoroughly.
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).

Questions Or Comments?

1-888-287-1915

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

for washing to decrease bacteria on the skin.

Purpose

Antibacterial

Warnings

For external use only.

Labe Copy

Directions
  • use to refill a pump bottle.
  • from pump bottle, apply onto wet hands.
  • lather and rinse thoroughly.
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).

Questions Or Comments? (Questions or comments?)

1-888-287-1915

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: 2026-02-15T11:56:29.772161 · Updated: 2026-03-14T22:54:59.525683