Antibacterial Handwash cucumber & Tea Tree

Antibacterial Handwash cucumber & Tea Tree
SPL v2
SPL
SPL Set ID 585ee68f-14fc-4b1f-b078-d31251bbc3f3
Route
TOPICAL
Published
Effective Date 2020-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Sodium Laureth-3 Sulfate Sodium Chloride Cocamidopropyl Betaine Coco Monoisopropanolamide Laureth-4 Glycerin Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600000 Mw) Methylchloroisothiazolinone Methylisothiazolinone Edetate Sodium Citric Acid Monohydrate Sulisobenzone .alpha.-tocopherol Acetate Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-25

Description

Active ingredient Benzalkonium Chloride 0.13%


Medication Information

Warnings and Precautions

Warning: Avoid contact with eyes. In case of contact flush with water. Keep out of direct sunlight. Do not drink, not edible. External use only.

Indications and Usage

USES for hand washing to decrease bacteria on the skin.

Dosage and Administration

Directions: Pump a small amount of soap into wet hands, rub hands together to create rich lather, then rinse.

Description

Active ingredient Benzalkonium Chloride 0.13%

Section 42229-5

Kill Germs and Odors

Distributed By:

Universal Distribution Center

96 Distribution Boulevard,

Edison, NJ 08817

Made in Turkey

Section 50565-1

Keep out of reach of children.

Section 51727-6

Ingredients: Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Cocamide MIPA, Laureth-4, Glycerin*, Polyquaternium-7*, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Citric Acid, Benzophenono-4, Tocopheryl Acetate, FD&C Blue No. 1, D&C Red No. 33

*Contains one or more of these ingredients.

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.13%

Packaging


Structured Label Content

Indications and Usage (34067-9)

USES for hand washing to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Directions: Pump a small amount of soap into wet hands, rub hands together to create rich lather, then rinse.

Warnings and Precautions (34071-1)

Warning: Avoid contact with eyes. In case of contact flush with water. Keep out of direct sunlight. Do not drink, not edible. External use only.

Section 42229-5 (42229-5)

Kill Germs and Odors

Distributed By:

Universal Distribution Center

96 Distribution Boulevard,

Edison, NJ 08817

Made in Turkey

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Ingredients: Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Cocamide MIPA, Laureth-4, Glycerin*, Polyquaternium-7*, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Citric Acid, Benzophenono-4, Tocopheryl Acetate, FD&C Blue No. 1, D&C Red No. 33

*Contains one or more of these ingredients.

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium Chloride 0.13%

Packaging


Advanced Ingredient Data


Raw Label Data

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