smart®

smart®
SPL v1
SPL
SPL Set ID 64eb1523-c746-4010-b55f-e43faa756617
Route
topical
Published
Effective Date 2020-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (71 mL)
Inactive Ingredients
aloe vera leaf carbomer homopolymer, unspecified type glycerin water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-29

Purpose

Antiseptic

Description

Ethyl alcohol 71% v/v


Medication Information

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
Uses
  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available
Purpose

Antiseptic

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

aloe vera gel, carbomer, glycerin, water

Description

Ethyl alcohol 71% v/v

Questions?

+1-718- 427- 5651

You may also report serious side effects to this phone number. 

Mon-Fri 9:00 AM - 5:00 PM

Section 42229-5

Manufactured for:

OZDEN KIMYA ve Plastik San. Tic. A.S.

Saray Mah. 191 Cad. No:4, Kazan, Ankara, TURKEY, 06980

COUNTRY OF ORIGIN: TURKEY

Tel: +90.312 815 50 14  www.ozdengroup.com

Section 50565-1

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

Packaging

Drug Facts

Active Ingredient

Ethyl alcohol 71% v/v


Structured Label Content

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
Uses
  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available
Purpose

Antiseptic

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
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)

aloe vera gel, carbomer, glycerin, water

Questions?

+1-718- 427- 5651

You may also report serious side effects to this phone number. 

Mon-Fri 9:00 AM - 5:00 PM

Section 42229-5 (42229-5)

Manufactured for:

OZDEN KIMYA ve Plastik San. Tic. A.S.

Saray Mah. 191 Cad. No:4, Kazan, Ankara, TURKEY, 06980

COUNTRY OF ORIGIN: TURKEY

Tel: +90.312 815 50 14  www.ozdengroup.com

Section 50565-1 (50565-1)

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

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Ethyl alcohol 71% v/v


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)