Abutol 

Abutol 
SPL v1
SPL
SPL Set ID 958aed16-c928-44fe-b48f-cf189727a6e4
Route
TOPICAL
Published
Effective Date 2020-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.12 g)
Inactive Ingredients
Water Sulisobenzone Citric Acid Monohydrate Coco Diethanolamide Cocamidopropyl Betaine Dmdm Hydantoin Fd&c Blue No. 1 Glycerin Methylchloroisothiazolinone Methylisothiazolinone Sodium Chloride Sodium Laureth-3 Sulfate Edetate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-30

Description

Benzalkonium chloride 0.12%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.12%

Uses

● for handwashing to decrease bacteria on the skin

● recommended for repeated use

Section 42229-5

with Moisturizer

Spring Waterfall - Cleans and soften hands

Distributed by:

American Brands and More

LLC, Wood Ridge, NJ 07075

Made in TURKEY

You may also report any serious side effects to

PO Box 328, Wood Ridge, NJ 07075-328

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 contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

● irritation and redness develop

● condition persists for more than 72 hours

Packaging

Directions

● wet hands and forearms. Apply 5 millilitre (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds

● rinse and repeat

● supervise children under 6 years of age when using this product to avoid swallowing

Drug Facts

Active Ingredient

Benzalkonium chloride 0.12%

Other Information

● store between 15-30°C (59-86°F)

● avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

Aqua, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, DMDM Hydantoin, FD&C Blue No.1, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA.


Structured Label Content

Uses

● for handwashing to decrease bacteria on the skin

● recommended for repeated use

Section 42229-5 (42229-5)

with Moisturizer

Spring Waterfall - Cleans and soften hands

Distributed by:

American Brands and More

LLC, Wood Ridge, NJ 07075

Made in TURKEY

You may also report any serious side effects to

PO Box 328, Wood Ridge, NJ 07075-328

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 contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

● irritation and redness develop

● condition persists for more than 72 hours

Packaging

Directions

● wet hands and forearms. Apply 5 millilitre (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 20 seconds

● rinse and repeat

● supervise children under 6 years of age when using this product to avoid swallowing

Drug Facts

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.12%

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, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, DMDM Hydantoin, FD&C Blue No.1, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Sodium Chloride, Sodium Laureth Sulfate, Tetrasodium EDTA.


Advanced Ingredient Data


Raw Label Data

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