Fonex antiseptic Hand Sanitizer

SPL v1

SPL

SPL Set ID d8ca588c-022e-41c9-9670-c9368c9a0cc5

Route

TOPICAL

Published

Effective Date 2020-07-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (80 mL)

Inactive Ingredients

Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-31

Description

Ethyl alcohol 80% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 80% v/v

Uses

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Section 42229-5

ALCOHOL BASED

Manufactured by: Itimat Kozmetik Urunleri San. Ve Tic. A.S.

Karadeniz District. M.Akif Avenue 1117/1 Street No:8

Gaziosmanpasa / ISTANBUL

COUNTRY OF ORIGIN: TURKEY

www.fonex.com.tr - [email protected]

Section 50565-1

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

Section 51727-6

Inactive ingredients glycerin, water

Section 53413-1

Questions? +1-646-301-0044

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Warnings

Flammable, keep away from fire/flame

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 thoroughly with product and allow to dry without wiping

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

Drug Facts

Active Ingredient

Ethyl alcohol 80% v/v

Other Information

• store between 15-30°C (59-86°F)

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

Structured Label Content

Uses

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Section 42229-5 (42229-5)

ALCOHOL BASED

Manufactured by: Itimat Kozmetik Urunleri San. Ve Tic. A.S.

Karadeniz District. M.Akif Avenue 1117/1 Street No:8

Gaziosmanpasa / ISTANBUL

COUNTRY OF ORIGIN: TURKEY

www.fonex.com.tr - [email protected]

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients glycerin, water

Section 53413-1 (53413-1)

Questions? +1-646-301-0044

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Purpose

Antiseptic

Warnings

Flammable, keep away from fire/flame

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 thoroughly with product and allow to dry without wiping

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

Drug Facts

Active Ingredient (Active ingredient)

Ethyl alcohol 80% v/v

Other Information (Other information)

• store between 15-30°C (59-86°F)

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

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available", "42229-5": "ALCOHOL BASED Manufactured by: Itimat Kozmetik Urunleri San. Ve Tic. A.S. Karadeniz District. M.Akif Avenue 1117/1 Street No:8 Gaziosmanpasa / ISTANBUL COUNTRY OF ORIGIN: TURKEY www.fonex.com.tr - info@fonex.com.tr", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients glycerin, water", "53413-1": "Questions? +1-646-301-0044 You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM", "Purpose": "Antiseptic", "Warnings": "Flammable, keep away from fire/flame 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", "Directions": "• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing", "Active ingredient": "Ethyl alcohol 80% v/v", "Other information": "• store between 15-30°C (59-86°F) • avoid freezing and excessive heat above 40°C (104°F)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:09.872936 · Updated: 2026-03-14T22:57:34.491747