Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID dcc7dbeb-4230-43df-9c0f-dfb7e59ffd44
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 Green Tea Leaf Citric Acid Monohydrate Cocamidopropyl Betaine Decyl Glucoside Glycerin Fd&c Green No. 3 Methylchloroisothiazolinone Methylisothiazolinone Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Polysorbate 20 Sodium Citrate Edetate Sodium Water Xanthan Gum D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-02-07
Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

Helps eliminate bacteria on hands.

Warnings

For exteral use only

Directions
  • use only to refill a Foaming Hand Soap pump bottle.
  • apply to dry hands
  • work into a rich foamy lather and rinse thoroughly.
Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

store at room temperature

Inactive Ingredients

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

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 A Doctor If

irritation and redness develop and last.

Structured Label Content

Uses

Helps eliminate bacteria on hands.

Purpose

Antibacterial

Warnings

For exteral use only

Directions
  • use only to refill a Foaming Hand Soap pump bottle.
  • apply to dry hands
  • work into a rich foamy lather and rinse 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, Camellia Sinensis Leaf Extract, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Fragrance (Parfum), Glycerin, Green 3 (CI 42053), Methylchloroisothiazolinone, Methylisothiazolinone, Polyquaternium-7, Polysorbate 20, Sodium Citrate, Tetrasodium EDTA, Water (Aqua), Xanthan Gum, Yellow 10 (CI 47005).

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 A Doctor If (Stop using this product and ask a 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: 2026-02-15T11:56:04.302080 · Updated: 2026-03-14T22:54:15.762833