STRATAMEDI HAND SANITIZER ANTIBACTERIAL GEL- hand sanitizer gel

STRATAMEDI Hand Sanitizer Antibacterial Gel by

Drug Labeling and Warnings

STRATAMEDI Hand Sanitizer Antibacterial Gel by is a Otc medication manufactured, distributed, or labeled by Strata USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Hand Sanitizer. Kills over 99.99% of most common germs within seconds. Our Sanitizer allows you to wash your hands whenever conventional soap and water are not avialble. Use as an aid to reduce exposure to infectious germs and to supplement daily handwashing..Meet US Government standards by protecting against exposure to bloodborne diseases

ACTIVE INGREDIENT

Ethyl Alcohol 70%...........................Antimicrobial

INACTIVE INGREDIENT

Water, Glycerin, Propylene Glycol, Carbomer

WARNINGS

Flammable. Keep away from flame. Keep out of eyes. In case of eye contact immediately flush eyes with water then contact physician. If swallowed, contact physician. Keep out of reach of children. Do not store above 110°F

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Children under 6 years of age should be supervised when using our products

INDICATIONS & USAGE

Hand Sanitizer

PRINCIPAL DISPLAY PANEL

250 mL NDC: 77004-20141

PRINCIPAL DISPLAY PANEL

3885 ml NDC: 77004-2014-3

INGREDIENTS AND APPEARANCE

STRATAMEDI HAND SANITIZER ANTIBACTERIAL GEL 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77004-202
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)	0.7 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.2 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.4 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77004-202-41	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/25/2020
2	NDC: 77004-202-42	472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/25/2020
3	NDC: 77004-202-43	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/25/2020

Labeler - Strata USA LLC (079851683)

Establishment
Name	Address	ID/FEI	Business Operations
Strata USA LLC		079851683	relabel(77004-202)