drug facts

drug facts
SPL v1
SPL
SPL Set ID 1f012011-1ea1-4b6c-8534-31f8b7d2d4dc
Route
topical
Published
Effective Date 2016-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water cocamidopropyl betaine decyl glucoside hydroxyethyl cellulose (5000 cps at 1%) glycerin poloxamer 124 edetate sodium polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) citric acid monohydrate aloe vera leaf methylchloroisothiazolinone methylisothiazolinone fd&c blue no. 1 ext. d&c violet no. 2

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-03-08
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Uses
  • For washing to decrease bacteria on the skin.
Purpose

Antibacterial

Directions

Squeeze onto wet hands or body sponge, work into a lather, wash skin, rinse and dry thoroughly.

Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Decyl Glucoside, Hydroxyethylcellulose, Glycerin, Poloxamer 124, Fragrance (Parfum), Tetrasodium EDTA, Polyquaternium-7, Citric Acid, Sodium Citrate, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

Description

Benzalkonium Chloride 0.13%

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Questions? Comments?

1-866-322-2439

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep Out of Reach of Children.
  • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop Using This Product and Ask A Doctor If

irritation or redness develops and lasts.

Structured Label Content

Warnings

For external use only.

Uses
  • For washing to decrease bacteria on the skin.
Purpose

Antibacterial

Directions

Squeeze onto wet hands or body sponge, work into a lather, wash skin, rinse and dry thoroughly.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Decyl Glucoside, Hydroxyethylcellulose, Glycerin, Poloxamer 124, Fragrance (Parfum), Tetrasodium EDTA, Polyquaternium-7, Citric Acid, Sodium Citrate, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ext. Violet 2 (CI 60730).

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Questions? Comments?

1-866-322-2439

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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.
Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)

irritation or redness develops and lasts.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:05.099494 · Updated: 2026-03-14T22:54:17.721451