FRESH PROTECT SKIN SANITIZER- benzalkonium chloride lotion 
Omega Tech Labs Inc.

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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Fresh Protect Skin Sanitizer Product

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)

PRINCIPAL DISPLAY PANEL
Fresh Protect
Skin Sanitizer Product
8 fl. oz. (237 ml)

FRESH PROTECT SKIN SANITIZER 
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20802-1500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.0013 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20802-1500-114 mL in 1 BOTTLE
2NDC:20802-1500-289 mL in 1 BOTTLE
3NDC:20802-1500-3237 mL in 1 BOTTLE, PUMP
4NDC:20802-1500-4473 mL in 1 BOTTLE, PUMP
5NDC:20802-1500-5800 mL in 1 BAG
6NDC:20802-1500-63785 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A12/16/2010
Labeler - Omega Tech Labs Inc. (019313817)
Establishment
NameAddressID/FEIBusiness Operations
Omega Tech Labs Inc019313817MANUFACTURE

Revised: 1/2011
Document Id: 89aaa721-8b3c-4167-8758-d5e41d05a430
Set id: 2483f742-10f7-4c0b-b76a-1773c852bfb7
Version: 2
Effective Time: 20110102
 
Omega Tech Labs Inc.