Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID c31fd094-9f4d-4154-a1a3-ffbcd4243a41
Route
TOPICAL
Published
Effective Date 2016-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Aloe Vera Leaf Bambusa Vulgaris Leaf Fd&c Blue No. 1 Citric Acid Monohydrate Cocamidopropyl Betaine Decyl Glucoside Glycerin Methylchloroisothiazolinone Methylisothiazolinone Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Polysorbate 20 D&c Red No. 33 Sodium Citrate Edetate Sodium Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-02-09
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use
  • Helps eliminate bacteria on the skin.
Warnings

For external use only.

Directions
  • Apply onto dry hands. Work into a lather, rinse and dry thoroughly.
Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • Store at room temperature.
Inactive Ingredients

Aloe Barbadensis Leaf Juice, Blue 1 (CI 42090), Camellia Sinensis Leaf Extract, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Fragrance (Parfum), Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Polyquaternium-7, Polysorbate 20, Red 33 (CI 17200), Sodium Citrate, Tetrasodium EDTA, Water (Aqua), Xanthan Gum

When Using This Product
  • Avoid contact with eyes. If contact occurs, rinse eyes 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 Doctor If
  • irritation and redness develop and last.

Structured Label Content

Use
  • Helps eliminate bacteria on the skin.
Purpose

Antibacterial

Warnings

For external use only.

Directions
  • Apply onto dry hands. Work into a lather, rinse and dry thoroughly.
Label Copy

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Other Information (Other information)
  • Store at room temperature.
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Blue 1 (CI 42090), Camellia Sinensis Leaf Extract, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Fragrance (Parfum), Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Polyquaternium-7, Polysorbate 20, Red 33 (CI 17200), Sodium Citrate, Tetrasodium EDTA, Water (Aqua), Xanthan Gum

When Using This Product (When using this product)
  • Avoid contact with eyes. If contact occurs, rinse eyes 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 Doctor If (Stop using this product and ask doctor if)
  • irritation and redness develop and last.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:04.284036 · Updated: 2026-03-14T22:54:15.762833