30d4fa59-3b4c-a7fc-e063-6294a90aed05

SPL v1
SPL
SPL Set ID 30d4fa59-3b4c-a7fc-e063-6294a90aed05
Route
topical
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
cocamidopropyl betaine sodium cocoamphoacetate water iodopropynyl butylcarbamate citric acid monohydrate methylisothiazolinone fd&c yellow no. 5 fd&c red no. 40 peg-150 distearate hydrogenated castor oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-01-01
Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Uses

for hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • wet hands as needed
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly.
Inactive Ingredients

Water (Aqua), Cocamidopropyl Betaine, Sodium Cocoamphoacetate, PEG-150 Distearate, Fragrance, PEG-40 Hydrogenated Castor Oil, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Yellow No. 5, FD&C Red No.40

Description

Benzalkonium Chloride 0.13%

Section 51945-4

Drug Facts

Benzalkonium Chloride 0.13%

Stop Use and Ask A Doctor If

irritation and redness develops.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Uses

for hand washing to decrease bacteria on the skin.

Purpose

Antibacterial

Directions
  • wet hands as needed
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cocamidopropyl Betaine, Sodium Cocoamphoacetate, PEG-150 Distearate, Fragrance, PEG-40 Hydrogenated Castor Oil, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Yellow No. 5, FD&C Red No.40

Section 51945-4 (51945-4)

Drug Facts

Benzalkonium Chloride 0.13%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

irritation and redness develops.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:46.005225 · Updated: 2026-03-14T23:08:02.764471