drug facts

drug facts
SPL v2
SPL
SPL Set ID 1c48c883-8bf4-4e48-9a33-d43ed4e06e3a
Route
topical
Published
Effective Date 2016-01-15
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 2016-01-14
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

Purpose

Antibacterial

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

Description

Benzalkonium Chloride 0.13%

Use

Helps eliminate 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.
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

Warnings

For external use only.

Purpose

Antibacterial

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

Use

Helps eliminate bacteria on the skin.

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.
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: 2026-02-15T11:56:03.012640 · Updated: 2026-03-14T22:54:14.381059