SPL v1
SPL
SPL Set ID 27ba0f30-e066-f240-e063-6394a90ae7cb
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
Description

Antibacterial

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Antibacterial

Uses

for hand washing to decrease bacteria on the skin.

Section 51945-4

Warnings

For external use only.

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

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

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

Uses

for hand washing to decrease bacteria on the skin.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings

For external use only.

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

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

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: 2026-02-15T12:04:31.615829 · Updated: 2026-03-14T23:05:20.270582