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

Active Ingredient

Benzalkonium Chloride

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.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Benzalkonium Chloride

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.

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.


Advanced Ingredient Data


Raw Label Data

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