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.

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

Section 55106-9

Benzalkonium chloride 0.13%


Structured Label Content

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.

Warnings and Precautions (34071-1)

For external use only.

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

Section 55106-9 (55106-9)

Benzalkonium chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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