Abutol

Abutol
SPL v1
SPL
SPL Set ID da877fc5-ce1e-4c09-ae6d-b22cdf61287b
Route
TOPICAL
Published
Effective Date 2020-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Polysorbate 20 Cocamidopropyl Betaine Corn Oil Lauryl Glucoside Polyglyceryl-2 Dipolyhydroxystearate Glyceryl Oleate Dicaprylyl Carbonate Edetate Sodium Phenoxyethanol Benzoic Acid Dehydroacetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-29

Description

Benzalkonium Chloride 0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Uses
  • hand wipes to decrease bacteria on the skin.
  • recommended for repeated use.
  • for use when soap and water are not available
Section 42229-5

PARIS

CITRUS GARDEN SCENT

SANITIZING WIPES

You may also report any serious side effects to

PO Box 328, Wood Ridge, NJ 07075-328 

ANTISEPTIC AGENT

  • Sanitizing formula to help reduce cross-contamination and risk of infection.
  • Leaves no stickiness or residue on hands.
  • Hands feel smooth, soft and refreshed.

To Open Package

  • Flip open dispensing lid
  • Locate wipe at center of roll and thread through small opening in lid
  • For best results dispense wipes at an angle
  • Always close lid securely between uses to retain moisture

Made in TURKEY

TO DISPOSE WIPE: Place in a waste basket after use.

DO NOT FLUSH

Lot Number and Exp Date on package

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Warnings

For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product • do not get into eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation or redness develop
  • condition persists for more than 72 hours
Packaging

Directions
  • open resealable label. Pull out wipes. Close resealable label to prevent drying out wipe hands thoroughly with product and allow to dry
  • dispose the wipe after use
  • supervise children under 6 years of age when using this product to avoid swallowing
  • do not flush
Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information
  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredients

Aqua, Glycerin, Propylene glycol, Parfum, Polysorbate-20, Cocamidopropyl Betaine, Corn Oil, Lauryl Glucoside, Polyglyceryl-2 DipolyhydroxyStearate, Glyceryl Oleate, Dicaprylyl Carbonate, Tetrasodium EDTA, Phenoxyethanol, Benzoic Acid, Dehydroacetic acid.


Structured Label Content

Uses
  • hand wipes to decrease bacteria on the skin.
  • recommended for repeated use.
  • for use when soap and water are not available
Section 42229-5 (42229-5)

PARIS

CITRUS GARDEN SCENT

SANITIZING WIPES

You may also report any serious side effects to

PO Box 328, Wood Ridge, NJ 07075-328 

ANTISEPTIC AGENT

  • Sanitizing formula to help reduce cross-contamination and risk of infection.
  • Leaves no stickiness or residue on hands.
  • Hands feel smooth, soft and refreshed.

To Open Package

  • Flip open dispensing lid
  • Locate wipe at center of roll and thread through small opening in lid
  • For best results dispense wipes at an angle
  • Always close lid securely between uses to retain moisture

Made in TURKEY

TO DISPOSE WIPE: Place in a waste basket after use.

DO NOT FLUSH

Lot Number and Exp Date on package

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Purpose

Antiseptic

Warnings

For external use only

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product • do not get into eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation or redness develop
  • condition persists for more than 72 hours
Packaging

Directions
  • open resealable label. Pull out wipes. Close resealable label to prevent drying out wipe hands thoroughly with product and allow to dry
  • dispose the wipe after use
  • supervise children under 6 years of age when using this product to avoid swallowing
  • do not flush
Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information (Other information)
  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Propylene glycol, Parfum, Polysorbate-20, Cocamidopropyl Betaine, Corn Oil, Lauryl Glucoside, Polyglyceryl-2 DipolyhydroxyStearate, Glyceryl Oleate, Dicaprylyl Carbonate, Tetrasodium EDTA, Phenoxyethanol, Benzoic Acid, Dehydroacetic acid.


Advanced Ingredient Data


Raw Label Data

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