SPL v1
SPL
SPL Set ID acc410b4-e9c2-0dd8-e053-2a95a90a50b0
Route
TOPICAL
Published
Effective Date 2017-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 g)
Inactive Ingredients
Hydrogen Peroxide Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-18

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

For hand sanitizing to decrease bacteria and viruses on the skin.

Recommended for repeated use.

Dosage and Administration

Read the entire label before using this product.

Pump a small amount of liquid into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Description

Benzalkonium Chloride 0.13%

Section 50565-1

Keep out of the reach of children.

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

Section 50566-9

Stop it and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6

Glycerin, Hydrogen Peroxide, Water

Section 51945-4

Section 55105-1

Anitseptic

Section 55106-9

Benzalkonium Chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

For hand sanitizing to decrease bacteria and viruses on the skin.

Recommended for repeated use.

Dosage and Administration (34068-7)

Read the entire label before using this product.

Pump a small amount of liquid into palm of hand.

Rub thoroughly over all surfaces of both hands for 15 seconds.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of the reach of children.

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

Section 50566-9 (50566-9)

Stop it and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Section 51727-6 (51727-6)

Glycerin, Hydrogen Peroxide, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anitseptic

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)