SPL v2
SPL
SPL Set ID dd18f969-5d4f-08eb-e053-2a95a90a119c
Route
TOPICAL
Published
Effective Date 2022-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (79.4 g)
Inactive Ingredients
Water Glycerin Peg/ppg-18/18 Dimethicone

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-05-02

Description

Remove the lid on the dispenser. Place opened pouch in the top of the dispenser. Pull wipe from center of the roll and thread through “X" on the underside of the lid. Close lid. Pull wipe at 90˚ angle


Medication Information

Warnings and Precautions

For external use only. Do not use in the eyes.

When using this product do not get into eyes. If contact occurs, rinse

thoroughly with water.

Indications and Usage

Uses: For handwashing to decrease bacteria on the skin.

Dosage and Administration

Remove the lid on the dispenser. Place opened pouch in the top of the dispenser. Pull wipe from center of the roll and thread through “X" on the underside of the lid. Close lid. Pull wipe at 90˚ angle

Description

Remove the lid on the dispenser. Place opened pouch in the top of the dispenser. Pull wipe from center of the roll and thread through “X" on the underside of the lid. Close lid. Pull wipe at 90˚ angle

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, Glycerin, PEG/PPG-18/18 Dimethicone

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Benzalkonium Chloride 0.1%


Structured Label Content

Indications and Usage (34067-9)

Uses: For handwashing to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Remove the lid on the dispenser. Place opened pouch in the top of the dispenser. Pull wipe from center of the roll and thread through “X" on the underside of the lid. Close lid. Pull wipe at 90˚ angle

Warnings and Precautions (34071-1)

For external use only. Do not use in the eyes.

When using this product do not get into eyes. If contact occurs, rinse

thoroughly with water.

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, Glycerin, PEG/PPG-18/18 Dimethicone

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)