drug facts

drug facts
SPL v1
SPL
SPL Set ID 0dd10661-e570-4faf-af89-5e347b0dfec9
Route
topical
Published
Effective Date 2017-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (1.3 mg)
Inactive Ingredients
water cocamidopropyl betaine polysorbate 20 glycerin decyl glucoside hydroxyethyl cellulose (5000 cps at 1%) aloe vera leaf green tea leaf polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) edetate sodium sodium citrate citric acid monohydrate sulisobenzone methylchloroisothiazolinone methylisothiazolinone d&c yellow no. 10 fd&c green no. 3

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-06-06
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
  • pump onto dry hands, work into a lather. Rinse thoroughly.
Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 10 (CI 47005), Green 3 (CI 42053).

Description

Benzalkonium Chloride 0.13%

Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Quesitons? Comments?

1-866-322-2439

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse 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 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
  • pump onto dry hands, work into a lather. Rinse thoroughly.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 10 (CI 47005), Green 3 (CI 42053).

Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Quesitons? Comments?

1-866-322-2439

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse 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 Doctor If (Stop using this product and ask 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: 2026-02-15T11:56:21.775830 · Updated: 2026-03-14T22:54:46.340416