SPL v2
SPL
SPL Set ID 8a80b935-d76b-49a1-87e5-44a2fe55f162
Route
TOPICAL
Published
Effective Date 2024-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Water Phenoxyethanol Glycerin Sodium Benzoate Polysorbate 20 Edetate Disodium Anhydrous .alpha.-tocopherol Acetate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Benzalkonium Chloride 0.1%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%

Uses

Instant hand antiseptic to decrease bacteria on the skin

Warnings

For external use only

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Stop use and ask a doctor if

■ hypersensitivity symptoms such as erythema, itching and dermatitis happen

■ skin irritation happens

------------------------------------------------------------------------------

Do not use

■ in combination with soap or antibacterial cleansing agents

■ the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin

-------------------------------------------------------------------------------

When using this product

■ aviod using repeatedly in the same area, skin irritation may occur

■ avoid getting into the eyes (if contact occurs, wash well with clean water)

■ if following abnormal symptoms persist, discontinue use :

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

-------------------------------------------------------------------------------

Keep out of reach of children

■ If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ Clean with wipes and let dry

■ Do not flush

Active Ingredient

Benzalkonium Chloride 0.1%

Other Information

■ Read the directions and warnings before use

■ Avoid freezing and excessive heat above 40 degree C (104 degree F)

Inactive Ingredients

Water, Phenoxyethanol, Glycerin, Sodium Benzoate, Polysorbate20, Disodium EDTA, Tocopheryl Acetate, Citric Acid

Keep Out of Reach of Children

■ If swallowed, get medical help or contact a Poison Control Center right away

Package Label.principal Display Panel


Structured Label Content

Uses

Instant hand antiseptic to decrease bacteria on the skin

Purpose (PURPOSE)

Antiseptic

Warnings (WARNINGS)

For external use only

------------------------------------------------------------------------------

Stop use and ask a doctor if

■ hypersensitivity symptoms such as erythema, itching and dermatitis happen

■ skin irritation happens

------------------------------------------------------------------------------

Do not use

■ in combination with soap or antibacterial cleansing agents

■ the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin

-------------------------------------------------------------------------------

When using this product

■ aviod using repeatedly in the same area, skin irritation may occur

■ avoid getting into the eyes (if contact occurs, wash well with clean water)

■ if following abnormal symptoms persist, discontinue use :

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

-------------------------------------------------------------------------------

Keep out of reach of children

■ If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ Clean with wipes and let dry

■ Do not flush

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride 0.1%

Other Information

■ Read the directions and warnings before use

■ Avoid freezing and excessive heat above 40 degree C (104 degree F)

Inactive Ingredients (Inactive ingredients)

Water, Phenoxyethanol, Glycerin, Sodium Benzoate, Polysorbate20, Disodium EDTA, Tocopheryl Acetate, Citric Acid

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

■ If swallowed, get medical help or contact a Poison Control Center right away

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


Advanced Ingredient Data


Raw Label Data

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