FRESH PROTECT SKIN SANITIZER- benzalkonium chloride lotion

Fresh Protect Skin Sanitizer by

Drug Labeling and Warnings

Fresh Protect Skin Sanitizer by is a Otc medication manufactured, distributed, or labeled by Omega Tech Labs Inc., Omega Tech Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

For hand sanitizing. To decrease bacteria on the skin.

Warnings

For external use only.

Do not use

in the eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or redness develops, or if condition persists more than 72 hours.

Keep out of reach of children.

Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply a small amount on your hands. Rub hands together until dry. When hands are visibly soiled, wash with soap and water.

Inactive Ingredients

Water, Emulsifying Wax NF, Behentrimonium Methosulfate, Centrimonium Chloride, Dimethicone, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate E, Retinyl Palmitate A, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Hydrolyzed Soy Protein, Butylene Glycol, Avena Sativa (Oat) Extract, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Tetrasodium EDTA, Peppermint Essential Oil.

PRINCIPAL DISPLAY PANEL

Fresh Protect
96.9% Natural
Skin Sanitizer Product
Kills 99.99% of Germs
No Alcohol
8 fl. oz. (237 ml)

INGREDIENTS AND APPEARANCE

FRESH PROTECT SKIN SANITIZER 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20802-1500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	.0013 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
SOY PROTEIN (UNII: R44IWB3RN5)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
AVENA SATIVA LEAF (UNII: 206PI19V7R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
EDETATE SODIUM (UNII: MP1J8420LU)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20802-1500-1	14 mL in 1 BOTTLE
2	NDC: 20802-1500-2	89 mL in 1 BOTTLE
3	NDC: 20802-1500-3	237 mL in 1 BOTTLE, PUMP
4	NDC: 20802-1500-4	473 mL in 1 BOTTLE, PUMP
5	NDC: 20802-1500-5	800 mL in 1 BAG
6	NDC: 20802-1500-6	3785 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	12/16/2010

Labeler - Omega Tech Labs Inc. (019313817)

Establishment
Name	Address	ID/FEI	Business Operations
Omega Tech Labs Inc		019313817	MANUFACTURE