Kutol F215f

Kutol F215f
SPL v4
SPL
SPL Set ID 56f50eda-5399-1bfe-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.013 mg)
Inactive Ingredients
Water Sodium Chloride Cetrimonium Chloride Lauramine Oxide Sorbitol Coco Monoethanolamide Sodium Lauriminodipropionate D&c Red No. 33 Fd&c Yellow No. 5 Peg-120 Methyl Glucose Dioleate Methylisothiazolinone Methylchloroisothiazolinone Edetate Disodium Anhydrous Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-17
Description

Active Ingredient Benzalkonium Chloride 0.13% w/w

Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not usein the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if redness and irritation appears and lasts.

Indications and Usage

Uses  Handwash to decrease bacteria on the skin.

Dosage and Administration

Directions

  • Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
  • Children under 6 years of age should be supervised when using this product.
Description

Active Ingredient Benzalkonium Chloride 0.13% w/w

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Inactive Ingredients

water, cetrimonium chloride, lauramine oxide, sorbitol, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, sodium lauraminodipropionate, citric acid, fragrance, disodium EDTA, methyisothiazolinone, methylchloroisothiazolinone, yellow 5, red 33

Section 51945-4

Section 55105-1

Purpose

Antibacterial Handwashing

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Structured Label Content

Indications and Usage (34067-9)

Uses  Handwash to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Directions

  • Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
  • Children under 6 years of age should be supervised when using this product.
Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not usein the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if redness and irritation appears and lasts.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Inactive Ingredients

water, cetrimonium chloride, lauramine oxide, sorbitol, cocamide MEA, sodium chloride, PEG-120 methyl glucose dioleate, sodium lauraminodipropionate, citric acid, fragrance, disodium EDTA, methyisothiazolinone, methylchloroisothiazolinone, yellow 5, red 33

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antibacterial Handwashing

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:53.556745 · Updated: 2026-03-14T23:06:01.213422