215bb9c7-2177-d87b-e063-6394a90a41b0

SPL v1
SPL
SPL Set ID 215bb9c7-2177-d87b-e063-6394a90a41b0
Route
topical
Published
Effective Date 2023-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-05-01
Purpose

Antibacterial

Description

Benzalkonium chloride 0.13 percent

Medication Information

Warnings

For external use only.

Purpose

Antibacterial

Directions

wet hands and apply soap.

lather all surfaces of hands and fingers by rubbing vigorously for at leat 20 seconds.

rinse hands well and dry.

Inactive Ingredients

water, cocamidopropyl betaine, PEG-150 distearate, sodium lauroamphoacetate, PEG-40 hydrogenated castor oil, fragrance, methylchloroisothiazolinone, methylisothiazolinone, citric acid, FD&C yellow no.5, FD&C red no.40

Description

Benzalkonium chloride 0.13 percent

Use

for handwahing to decrease bacteria on the skin

Section 51945-4

Active Ingredient

Benzalkonium chloride 0.13 percent

When Using This Product

avoid contact with eyes, in case of eye contact, flush with water.

Stop Use and Ask A Doctor If

irritation or redness develops, condition persists for more than 72 hours.

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.

Purpose

Antibacterial

Directions

wet hands and apply soap.

lather all surfaces of hands and fingers by rubbing vigorously for at leat 20 seconds.

rinse hands well and dry.

Inactive Ingredients (Inactive ingredients)

water, cocamidopropyl betaine, PEG-150 distearate, sodium lauroamphoacetate, PEG-40 hydrogenated castor oil, fragrance, methylchloroisothiazolinone, methylisothiazolinone, citric acid, FD&C yellow no.5, FD&C red no.40

Use

for handwahing to decrease bacteria on the skin

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13 percent

When Using This Product (When using this product)

avoid contact with eyes, in case of eye contact, flush with water.

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

irritation or redness develops, condition persists for more than 72 hours.

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: 2026-02-15T12:03:34.548655 · Updated: 2026-03-14T23:03:43.204876