FORTO ANTISEPTIC HAND SANITIZER- ethyl alcohol gel
Master Paints & Chemical Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FORTO Antiseptic Hand Sanitizer

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

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

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 and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

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

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 Water (Aqua), Glycerin, Carbomer, Triethanolamine

Questions? +1-787-740-5254

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

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

HEAL+H

Moisturizing GEL

70% Concentration Ethyl Alcohol

Water-free protection

Manufactured by: Master Pants & Chemical Corp, Rd 127 Km 12.7 Bo Magas, Guayanilla, PR, 00656

ANTISEPTIC HAND SANITIZER MOISTURIZING GEL

Antiseptic Hand Sanitizer Moisturizing GEL by FORTO ® is a gel type antibacterial hand sanitizer designed to instantly sanitize without water or towels. Formulated with 70% ethyl alcohol, Antiseptic Hand Sanitizer Moisturizing GEL helps prevent bacterial transfers. Antiseptic Hand Sanitizer Moisturizing GEL contains moisturizing agents, evaporates instantly with no sticky residue, leaving hands sanitized, smooth and conditioned.

NOTE: Alcohol is not a substitute for regular hand hygiene or removing heavy soil from hands. Hands should be washed as soon as soap and water are available.

www.forto-pr.com

Packaging

image description

FORTO ANTISEPTIC HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73869-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	605.7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73869-101-10	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2020
2	NDC:73869-101-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2020
3	NDC:73869-101-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2020
4	NDC:73869-101-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2020
5	NDC:73869-101-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2020
6	NDC:73869-101-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/02/2020

Labeler - Master Paints & Chemical Corp (158762943)

Name	Address	ID/FEI	Business Operations
Establishment
Master Paints & Chemical Corp		158762943	manufacture(73869-101)

Revised: 2/2023

Document Id: f54f947b-37f2-1bd4-e053-2a95a90a7bd8

Set id: 9b6cd869-7258-4176-b145-4ee6427bdc2d

Version: 3

Effective Time: 20230222

Master Paints & Chemical Corp