Ndc 51316-704

Ndc 51316-704
SPL v3
SPL
SPL Set ID e78ad7c1-23ab-6fec-e053-2995a90a16c0
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
Decyl Glucoside Hydroxyethyl Cellulose (2000 Cps At 1%) Edetate Sodium Sodium Citrate Sulisobenzone Polysorbate 20 Fragrance Clean Orc0600327 Bambusa Vulgaris Leaf Polyquaternium-7 Citric Acid Monohydrate Methylisothiazolinone D&c Red No. 33 Cocamidopropyl Betaine Aloe Vera Leaf Cocos Nucifera (coconut) Fruit Propylene Glycol Methylchloroisothiazolinone Fd&c Blue No. 1 Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-15

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

Ask a doctor if: Irritation or redness develops and lasts

Section 50567-7

Avoid contact with eyes. In case of contact, rinse throughly with water.

Section 51727-6

Water( Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis, Leaf Juice, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone -4, Methylcholoroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Red 33 (Cl 17200)

Section 51945-4

Section 55105-1

Hand washing

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)

Ask a doctor if: Irritation or redness develops and lasts

Section 50567-7 (50567-7)

Avoid contact with eyes. In case of contact, rinse throughly with water.

Section 51727-6 (51727-6)

Water( Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis, Leaf Juice, Cocos Nucifera (Coconut) Fruit Extract, Bambusa Vulgaris Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone -4, Methylcholoroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Red 33 (Cl 17200)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hand washing

Section 55106-9 (55106-9)

Benzalkonium Chloride


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)