3a40a31d-4032-71ba-e063-6294a90a48dc

SPL v2
SPL
SPL Set ID 3a40a31d-4032-71ba-e063-6294a90a48dc
Route
topical
Published
Effective Date 2025-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-09-15

Description

Benzalkonium chloride 0.13%


Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Benzalkonium chloride 0.13%

Indications and Usage

Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water.

Dosage and Administration

Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.

Description

Benzalkonium chloride 0.13%

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

Water

Section 51945-4

ACTIVE INGREDIENT:

Benzalkonium chloride 0.13%

PURPOSE:

First Aid Antiseptic

USES:

Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water.

WARNINGS:

For external use only.

DO NOT USE:

in the eyes. Ifthis happens, rinse thoroughly with water.

STOP USE and ASK A DOCTOR:

If irritation or redness develop and persists for more than 72 hours.

CAUTION:

Keep out of reach of children, If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.

OTHER INFORMATION:

Store at room temperature.

INACTIVE INGREDIENTS:

water

Section 55105-1

First Aid Antiseptic


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Benzalkonium chloride 0.13%

Indications and Usage (34067-9)

Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water.

Dosage and Administration (34068-7)

Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.

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)

Water

Section 51945-4 (51945-4)

ACTIVE INGREDIENT:

Benzalkonium chloride 0.13%

PURPOSE:

First Aid Antiseptic

USES:

Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water.

WARNINGS:

For external use only.

DO NOT USE:

in the eyes. Ifthis happens, rinse thoroughly with water.

STOP USE and ASK A DOCTOR:

If irritation or redness develop and persists for more than 72 hours.

CAUTION:

Keep out of reach of children, If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.

OTHER INFORMATION:

Store at room temperature.

INACTIVE INGREDIENTS:

water

Section 55105-1 (55105-1)

First Aid Antiseptic


Advanced Ingredient Data


Raw Label Data

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