8a80b935-d76b-49a1-87e5-44a2fe55f162

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

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1%


Medication Information

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

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Keep out of reach of children

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

Uses

Instant hand antiseptic to decrease bacteria on the skin

Purpose

Antiseptic

Directions

■ Clean with wipes and let dry

■ Do not flush

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

Description

Benzalkonium Chloride 0.1%

Active Ingredient

Benzalkonium Chloride 0.1%

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

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

Uses

Instant hand antiseptic to decrease bacteria on the skin

Purpose (PURPOSE)

Antiseptic

Directions

■ Clean with wipes and let dry

■ Do not flush

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

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride 0.1%

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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