Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2b03f64e-eb6d-40e7-9bc3-8f6663117660
Route
TOPICAL
Published
Effective Date 2015-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Cetrimonium Chloride Glycerin Lauramidopropylamine Oxide Coco Monoethanolamide Sodium Chloride Peg-120 Methyl Glucose Dioleate Citric Acid Monohydrate Edetate Sodium Sodium Sulfate Methylchloroisothiazolinone Methylisothiazolinone Fd&c Red No. 40 Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-11-26

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 Liquid Hand Soap pump bottle. Apply onto wet hands
  • Lather and rinse thoroughly.
Label Copy

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

store at room temperature

Inactive Ingredients

Water (Aqua), Glycerin, Cetrimonium Chloride, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (CI 17200), Red 40 (CI 16035), Yellow 5 (CI 19140).

Questions Or Comments?

1-888-287-1915

When Using This Product

avoid contact with eyes. In case of contact, flush 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 Liquid Hand Soap pump bottle. Apply onto wet hands
  • 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)

Water (Aqua), Glycerin, Cetrimonium Chloride, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (CI 17200), Red 40 (CI 16035), Yellow 5 (CI 19140).

Questions Or Comments? (Questions or comments?)

1-888-287-1915

When Using This Product (When using this product)

avoid contact with eyes. In case of contact, flush 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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