SPL v3
SPL
SPL Set ID b46585f4-fd2b-0900-e053-2995a90a4a69
Route
TOPICAL
Published
Effective Date 2020-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Water Citric Acid Monohydrate Dihydroxyethyl Cocamine Oxide Acetamidoethoxyethanol Cocamidopropyl Pg-dimonium Chloride Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-01
Description

Drug Facts

Medication Information

Recent Major Changes

Drug Facts

Warnings and Precautions

For external use only

Description

Drug Facts

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a Poison Control Center immediately.

Section 50566-9

Stop use 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

Water, C9-11 Pareth-6, Cocamidopropyl PG-dimonium chloride phosphate, Dihydroxyethyl cocamine oxide, Acetamidoethanol, Citric acid.

Section 51945-4

90 CT 74146-242-97

Section 55105-1

Antiseptic

Section 55106-9

Benzalkonium chloride 0.1%

Directions

Wet hands thoroughly with product. Discard wipe in trash receptacle after use. Do not flush. Rub hands together briskly until dry.

Other Information

Store in a cool dry place below 104 F

Structured Label Content

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Recent Major Changes (34066-1)

Drug Facts

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use 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)

Water, C9-11 Pareth-6, Cocamidopropyl PG-dimonium chloride phosphate, Dihydroxyethyl cocamine oxide, Acetamidoethanol, Citric acid.

Section 51945-4 (51945-4)

90 CT 74146-242-97

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Benzalkonium chloride 0.1%

Directions

Wet hands thoroughly with product. Discard wipe in trash receptacle after use. Do not flush. Rub hands together briskly until dry.

Other Information (Other information)

Store in a cool dry place below 104 F

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:17.909142 · Updated: 2026-03-14T22:59:11.576282