SPL v1
SPL
SPL Set ID 42d2fc44-c821-6cf3-e063-6294a90a6ed7
Route
TOPICAL
Published
Effective Date 2025-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Phenoxyethanol Diazolidinyl Urea Butylparaben Polyoxyl 40 Hydrogenated Castor Oil Water Methylparaben Propylene Glycol Propylparaben Isobutylparaben Glycerin Ethylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-05

Description

Benzalkonium chloride 0.13% Purpose - Antiseptic


Medication Information

Warnings and Precautions

Warnings

For external use only

May irritate eyes

Indications and Usage

Tear V notch located on top of the plastic bag.

Pull out the first wipe approximately 6 to 8 inches from the center of the roll.

Place entire bag inside of center pull dispenser.

Thread the wipe through the opening on the dispenser.

Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up.

Apply topically to the skin to help prevent cross contamination.

Recommended for repeated use.

Dries in seconds.

Dosage and Administration

Tear V notch located on top of the plastic bag.

Pull out the first wipe approximately 6 to 8 inches from the center of the roll.

Description

Benzalkonium chloride 0.13% Purpose - Antiseptic

Section 50565-1

Keep out of reach of children

unless under adult supervision

Section 51727-6

Aloe barbadensis extract, diazolidinyl urea, fragrance, glycerin, lauryl betain, methylparaben/ethylparaben/propylparaben/butylparaben /isobutylparaben/phenoxyethanol, PEG-40 hydrogenated castor oil, propylene glycol, water.

Section 51945-4

Section 55105-1

For hand sanitizing to decrease bacteria on the skin.

Section 55106-9

Benzalkonium chloride 0.13% Purpose - Antiseptic


Structured Label Content

Indications and Usage (34067-9)

Tear V notch located on top of the plastic bag.

Pull out the first wipe approximately 6 to 8 inches from the center of the roll.

Place entire bag inside of center pull dispenser.

Thread the wipe through the opening on the dispenser.

Close the lid of the dispenser. Wipe dispensing tension may be adjusted on the top of the dispenser. Dispenser must be mounted with wipes dispensing up.

Apply topically to the skin to help prevent cross contamination.

Recommended for repeated use.

Dries in seconds.

Dosage and Administration (34068-7)

Tear V notch located on top of the plastic bag.

Pull out the first wipe approximately 6 to 8 inches from the center of the roll.

Warnings and Precautions (34071-1)

Warnings

For external use only

May irritate eyes

Section 50565-1 (50565-1)

Keep out of reach of children

unless under adult supervision

Section 51727-6 (51727-6)

Aloe barbadensis extract, diazolidinyl urea, fragrance, glycerin, lauryl betain, methylparaben/ethylparaben/propylparaben/butylparaben /isobutylparaben/phenoxyethanol, PEG-40 hydrogenated castor oil, propylene glycol, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For hand sanitizing to decrease bacteria on the skin.

Section 55106-9 (55106-9)

Benzalkonium chloride 0.13% Purpose - Antiseptic


Advanced Ingredient Data


Raw Label Data

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