Ndc 51316-705

Ndc 51316-705
SPL v2
SPL
SPL Set ID e582bdcf-0d8b-39f1-e053-2995a90a01f2
Route
TOPICAL
Published
Effective Date 2022-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (130 mg)
Inactive Ingredients
Water Hydroxyethyl Cellulose, Unspecified Edetate Sodium Direct Blue 1 Green Tea Leaf Methylisothiazolinone Sodium Citrate Citric Acid Monohydrate Sulisobenzone Methylchloroisothiazolinone Aloe Vera Leaf Propylene Glycol Glycerin Ext. D&c Violet No. 2 Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600 Kd) Cocamidopropyl Betaine Fragrance Clean Orc0600327 Polysorbate 20 Decyl Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-04
Description

Benzalkonium Chloride

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Helps eliminate bacteria on the skin

Dosage and Administration

Apply onto dry hands, work into a lather, rinse and dry throughly.

Description

Benzalkonium Chloride

Section 44425-7

Store at room temperature

Section 50565-1

In case of accidental ingestion, seek medical attention or contact a poison control centre immediately.

Section 50566-9

Stop use and ask a doctor ifirritation or redness develops and lasts

Section 50567-7

Avoid contact with eyes, If this occurs, rinse throughly with water.

Section 51727-6

Water( Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone -4, Methylcholoroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Ext. Violet 2 (Cl 60730).

Section 51945-4

Section 55105-1

Antibacterial- Helps eliminate bacteria on hands.

Section 55106-9

Benzalkonium Chloride

Structured Label Content

Indications and Usage (34067-9)

Helps eliminate bacteria on the skin

Dosage and Administration (34068-7)

Apply onto dry hands, work into a lather, rinse and dry throughly.

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Store at room temperature

Section 50565-1 (50565-1)

In case of accidental ingestion, seek medical attention or contact a poison control centre immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifirritation or redness develops and lasts

Section 50567-7 (50567-7)

Avoid contact with eyes, If this occurs, rinse throughly with water.

Section 51727-6 (51727-6)

Water( Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone -4, Methylcholoroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Ext. Violet 2 (Cl 60730).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antibacterial- Helps eliminate bacteria on hands.

Section 55106-9 (55106-9)

Benzalkonium Chloride

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.946616 · Updated: 2026-03-14T23:04:15.032207