drug facts

drug facts
SPL v1
SPL
SPL Set ID 9d7e02a9-e712-4bf7-b591-4e2b9f57ac53
Route
topical
Published
Effective Date 2016-08-22
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 aloe vera leaf green tea leaf polyquaternium-7 (70/30 acrylamide/dadmac; 1600000 mw) xanthan gum edetate sodium sodium citrate citric acid monohydrate sulisobenzone methylchloroisothiazolinone methylisothiazolinone d&c red no. 33 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-08-21
Purpose

Antibacterial

Description

Benzalkonium chloride 0.13%

Medication Information

Warnings

For external use only: hands only

Purpose

Antibacterial

Directions
  • wet hands
  • apply palmful to hands
  • scrub and rinse thoroughly
Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extact, Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (CI 17200), Yellow 5 (CI 19140).

Description

Benzalkonium chloride 0.13%

Questions?

Call 1-888-287-1915

Use

for handwashing to decrease bacteria on the skin.

Label Copy

Active Ingredient

Benzalkonium chloride 0.13%

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop Use and Ask A Doctor If
  • irritation or redness develops.
  • condition persists for more than 72 hours.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Warnings

For external use only: hands only

Purpose

Antibacterial

Directions
  • wet hands
  • apply palmful to hands
  • scrub and rinse thoroughly
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extact, Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (CI 17200), Yellow 5 (CI 19140).

Questions?

Call 1-888-287-1915

Use

for handwashing to decrease bacteria on the skin.

Label Copy (Label copy)

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13%

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation or redness develops.
  • condition persists for more than 72 hours.
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, 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: 2026-02-15T11:56:09.267162 · Updated: 2026-03-14T22:54:24.786834