SPL v1
SPL
SPL Set ID 7cbaf90a-37f7-4b71-85e6-caa8a1013d57
Route
TOPICAL
Published
Effective Date 2017-04-28
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 Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-27
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

for handwashing to decrease bacteria on the skin.

Warnings

For external use only; hands only

Directions
  • wet hands
  • apply palmful to hands
  • scrub and rinse thoroughly.
Label Copy

Questions?

call 1-888-287-1915

Active Ingredient

Benzalkonium Chloride 0.13%

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 5 (CI 19140), Red 33 (CI 17200).

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

Use

for handwashing to decrease bacteria on the skin.

Purpose

Antibacterial

Warnings

For external use only; hands only

Directions
  • wet hands
  • apply palmful to hands
  • scrub and rinse thoroughly.
Label Copy

Questions?

call 1-888-287-1915

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

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 5 (CI 19140), Red 33 (CI 17200).

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: 2026-02-15T11:56:18.986122 · Updated: 2026-03-14T22:54:43.254033