Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 42051b24-d044-4aaf-930c-d64a95e7ebe1
Route
TOPICAL
Published
Effective Date 2020-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.16 g)
Inactive Ingredients
Water Glycerin Sodium Benzoate Polysorbate 20 Edetate Disodium Anhydrous Phenoxyethanol .alpha.-tocopherol Acetate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-01

Description

Benzalkonium Chloride 0.1%

Purpose

antiseptic


Medication Information

Purpose

antiseptic

Description

Benzalkonium Chloride 0.1%

Uses

■instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■instant hand antiseptic to decrease bacteria on the skin

Warnings

Warnings

For external use only



When using this product

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ When used repeatedly in the same area, skin irritation may occur.

■Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■Do not use in combination with soap or antibacterial cleansing agents.

Directions

■ Scrub and wipe off the hand and skin, which are used individually or if necessary.

Active Ingredient

Benzalkonium Chloride 0.1%

Other Information

■ Read the directions and warnings before use

■ Avoid freezing and excessive heat above 40 ℃ (104 ℉)

Inactive Ingredients

Water, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Tocopheryl acetate, Citric acid

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

■instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■instant hand antiseptic to decrease bacteria on the skin

Purpose (PURPOSE)

antiseptic

Warnings (WARNINGS)

Warnings

For external use only



When using this product

■ if following abnormal symptoms persist, discontinue use

Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

■ Stop immediately and consult a doctor if you experience

1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

2) Skin Irritation

3) Following Instructions when using medication

(1) For external use only (Do not use internally)

(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

■ When used repeatedly in the same area, skin irritation may occur.

■Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one areas that have been medically treated with a cast or bandage.

■Do not use in combination with soap or antibacterial cleansing agents.

Directions

■ Scrub and wipe off the hand and skin, which are used individually or if necessary.

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride 0.1%

Other Information (Other information)

■ Read the directions and warnings before use

■ Avoid freezing and excessive heat above 40 ℃ (104 ℉)

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Tocopheryl acetate, Citric acid

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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