Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 0b4ac673-b7ac-4464-b8cd-82caee320f79
Route
TOPICAL
Published
Effective Date 2020-03-18
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 Hypromelloses Aloe Vera Leaf Green Tea Leaf Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Edetate Sodium Sodium Citrate Citric Acid Monohydrate Sulisobenzone Methylchloroisothiazolinone Methylisothiazolinone D&c Yellow No. 10 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-07-05

Description

Benzalkonium Chloride 0.13%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Uses

helps eliminate bacteria on hands.

Warnings

For external use only.

Directions
  • use only to refill a foaming hand soap pump bottle.
  • from pump bottle, apply to dry hands.
  • work into a rich foamy lather and rinse thoroughly.
Label Copy

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 10 (CI 47005), Green 3 (CI 42053).

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 develops and lasts.


Structured Label Content

Uses

helps eliminate bacteria on hands.

Purpose

Antibacterial

Warnings

For external use only.

Directions
  • use only to refill a foaming hand soap pump bottle.
  • from pump bottle, apply to dry hands.
  • work into a rich foamy lather and rinse thoroughly.
Label Copy (Label copy)

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 10 (CI 47005), Green 3 (CI 42053).

When Using This Product Avoid (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 develops and lasts.


Advanced Ingredient Data


Raw Label Data

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