PROSHIELD HAND SANITIZER- ethyl alcohol gel

PROSHIELD HAND SANITIZER by

Drug Labeling and Warnings

PROSHIELD HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by GENC GIDA KOZMETIK VE KIMYASAL URUNLER SANAYI VE TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product ▪ do not use in or near the eyes. In case of contact, rinse thoroughly with water ▪ avoid contact wth broken skin ▪ do not inhale or ingest

Stop use and ask a doctor if ▪ irritation or rash appears and lasts for more than 72 hours.

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

DOSAGE & ADMINISTRATION

Directions ▪ place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry
▪ children under 6 years of age should be supervised when using this product.

STORAGE AND HANDLING

Other information ▪ store below 106°F (41°C)
▪ may discolor certain fabrics or surfaces

Inactive ingredients

Water, glycerin, carbomer, triethanolamine, fragrance

SPL UNCLASSIFIED SECTION

HYGIENIC HAND RUB

MAXIMUM PROTECTION

ADVANCED FORMULA

KILLS 99.99% OF GERMS

FAST*

NO WATER - NO TOWELS

INSTANT RESULTS

Imported By:

Evergreen USA LLC

Hoboken, NJ 07030

www.egreenusa.com 

PRODUCT OF TURKEY

*Effective at eliminating more than 99.99% of many common harmful germs and bacteria.

Packaging

INGREDIENTS AND APPEARANCE

PROSHIELD HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74600-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74600-001-85	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

Labeler - GENC GIDA KOZMETIK VE KIMYASAL URUNLER SANAYI VE TICARET LIMITED SIRKETI (356827969)

Establishment
Name	Address	ID/FEI	Business Operations
GENC GIDA KOZMETIK VE KIMYASAL URUNLER SANAYI VE TICARET LIMITED SIRKETI		356827969	manufacture(74600-001)