SPL v1
SPL
SPL Set ID a792e38f-b7d9-56ea-e053-2995a90a2cc1
Route
TOPICAL
Published
Effective Date 2020-06-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Polysorbate 20 Trimethylenediaminetetraacetic Acid Glycerin Ethylhexylglycerin Sodium Pyrrolidone Carboxylate Water Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01
Description

Antibacterial

Medication Information

Warnings and Precautions

For external use only.Keep out of the eyes. In case of eye contact, rinse with water.If irritation develps discontinue use and consult a doctor if irritation persists more than 72 hours. If swallowed, seek medical attention or contact a Poison Control Center.

Indications and Usage

decreases bacteria on skin. recommended for repeated use

Dosage and Administration

Take wipe and rub thoroughly over all surfaces of both hands.Rrub hands together briskly to dry·dispose of wipe. For children under 2 years ask a doctor before use.

Description

Antibacterial

Section 50565-1

Keep out of the reach of children, except with adult supervision.

Section 51727-6

Aqua, Glycerin, Phenoxyethanol, Parfum, Polysorbate 20, Sodium PCA, Tetrasodium EDTA, Ethylhexylglycerin, Citric Acid

Section 51945-4

Section 55105-1

Antibacterial

Section 55106-9

Benzalkonium chloride 0.13%

Structured Label Content

Indications and Usage (34067-9)

decreases bacteria on skin. recommended for repeated use

Dosage and Administration (34068-7)

Take wipe and rub thoroughly over all surfaces of both hands.Rrub hands together briskly to dry·dispose of wipe. For children under 2 years ask a doctor before use.

Warnings and Precautions (34071-1)

For external use only.Keep out of the eyes. In case of eye contact, rinse with water.If irritation develps discontinue use and consult a doctor if irritation persists more than 72 hours. If swallowed, seek medical attention or contact a Poison Control Center.

Section 50565-1 (50565-1)

Keep out of the reach of children, except with adult supervision.

Section 51727-6 (51727-6)

Aqua, Glycerin, Phenoxyethanol, Parfum, Polysorbate 20, Sodium PCA, Tetrasodium EDTA, Ethylhexylglycerin, Citric Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antibacterial

Section 55106-9 (55106-9)

Benzalkonium chloride 0.13%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:49.972391 · Updated: 2026-03-14T22:57:07.300794