47993-402 - DailyMed Details

47993-402

SPL v2

SPL

SPL Set ID 29cc2729-ded0-4eab-be74-9c2474837c40

Route

TOPICAL

Published

Effective Date 2020-07-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.3 g)

Inactive Ingredients

Water Glycerin Carboxymethylcellulose Sodium Triethanolamine Benzoate Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-07-24

Description

Active ingredients Benzalkonium Chloride 0.3%

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Indications and Usage

Uses：

For hand sanitizing.

Dosage and Administration

Directions:

Squeeze small amount in your palm and briskly rub hands together until dry.

Description

Active ingredients Benzalkonium Chloride 0.3%

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if skin irritation develops.

Section 50567-7

When using this product Keep out of eyes. Do not inhale or ingest.

Section 51727-6

Inactive Ingredients:

Water,Glycerine,Cellulose,Triethanolamine,Ethoxylated hydrogenated castor oil,Fragrance.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Benzalkonium Chloride 0.3%

Structured Label Content

Indications and Usage (34067-9)

Uses：

For hand sanitizing.

Dosage and Administration (34068-7)

Directions:

Squeeze small amount in your palm and briskly rub hands together until dry.

Warnings and Precautions (34071-1)

Warnings:

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation develops.

Section 50567-7 (50567-7)

When using this product Keep out of eyes. Do not inhale or ingest.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water,Glycerine,Cellulose,Triethanolamine,Ethoxylated hydrogenated castor oil,Fragrance.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Benzalkonium Chloride 0.3%

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHANOLAMINE BENZOATE", "unii": "M3EN4GC19W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED CASTOR OIL", "unii": "ZF94AP8MEY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses： For hand sanitizing.", "34068-7": "Directions: Squeeze small amount in your palm and briskly rub hands together until dry.", "34071-1": "Warnings: For external use only. ", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if skin irritation develops.", "50567-7": "When using this product Keep out of eyes. Do not inhale or ingest.", "51727-6": "Inactive Ingredients: Water,Glycerine,Cellulose,Triethanolamine,Ethoxylated hydrogenated castor oil,Fragrance.", "55105-1": "Antiseptic", "55106-9": "Active ingredients Benzalkonium Chloride 0.3%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:59.702913 · Updated: 2026-03-14T22:58:49.351511