Topcare Antibacterial Hand Soap.

Topcare Antibacterial Hand Soap.
SPL v2
SPL
SPL Set ID e60ff14a-f78d-c9fa-e053-2995a90a7f10
Route
TOPICAL
Published
Effective Date 2022-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (130 mg)
Inactive Ingredients
Citric Acid Monohydrate Edetate Sodium Methylisothiazolinone Glycerin Water Fd&c Red No. 40 Lauramidopropylamine Oxide Cetrimonium Chloride Sodium Chloride Coco Monoethanolamide Peg-120 Methyl Glucose Dioleate Methylchloroisothiazolinone Fd&c Yellow No. 5 D&c Red No. 33 Sodium Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-12

Description

Benzalkonium Chloride


Medication Information

Warnings and Precautions

For External Use only

Indications and Usage

Directions

. Use only to refill a Liquid Hand Soap pump bottle.

. From pump bottle, apply onto wet hands.

. Lather and rinse thoroughly.

Description

Benzalkonium Chloride

Section 44425-7

Store at room temperature

Section 50565-1

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

Section 50566-9

Stop using this product and ask a doctor if irritation or redness develops and lasts.

Section 50567-7

Avoid contact with eyes. In case of contact, flush with water

Section 51727-6

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

Section 51945-4

Section 55105-1

Handwashing

Section 55106-9

Benzalkonium Chloride

Dosage Section

Topical use only. Use when required.


Structured Label Content

Indications and Usage (34067-9)

Directions

. Use only to refill a Liquid Hand Soap pump bottle.

. From pump bottle, apply onto wet hands.

. Lather and rinse thoroughly.

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, get medical help or contact a Poison Control Center immediately

Section 50566-9 (50566-9)

Stop using this product and ask a doctor if irritation or redness develops and lasts.

Section 50567-7 (50567-7)

Avoid contact with eyes. In case of contact, flush with water

Section 51727-6 (51727-6)

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Handwashing

Section 55106-9 (55106-9)

Benzalkonium Chloride

Dosage Section

Topical use only. Use when required.


Advanced Ingredient Data


Raw Label Data

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