Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 746b7dac-baef-47bd-812e-d6056f44d4f0
Route
TOPICAL
Published
Effective Date 2020-05-19
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 NOT FINAL Active Since 2020-05-01

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

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

■ avoid 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

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ 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 ℃ (104 ℉)

Inactive Ingredient

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

Keep Out of Reach of Children

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

Package Label Kosette Sanitizer Wipes / 108g(20wipes)

Package Label Kosette Sanitizer Wipes / 432g(80wipes)


Structured Label Content

Uses

■ Instant hand antiseptic to decrease bacteria on the skin

Purpose (PURPOSE)

Antiseptic

Warnings (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

■ avoid 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

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ Do not flush

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 Ingredient (INACTIVE INGREDIENT)

Water, Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, 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 Posion Control Center right away

Package Label Kosette Sanitizer Wipes / 108g(20wipes) (Package Label - kosette SANITIZER WIPES / 108g(20wipes))

Package Label Kosette Sanitizer Wipes / 432g(80wipes) (Package Label - kosette SANITIZER WIPES / 432g(80wipes))


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)