FRESH PROTECT SKIN SANITIZER- benzalkonium chloride liquid 
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 Foam

DRUG FACTS

Active Ingredient

Benzalkonium chloride 0.1%

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, Aloe Barbadensis Leaf Extract, Glycerin, Citrus Grandis (Grapefruit) Seed Extract, Thymus Vulgaris (Thyme) Extract, Camellia Sinensis Leaf (Green Tea) Extract, Avena Sativa (Oat) Extract, Peppermint Essential Oil, Polysorbate 20, Potassium Sorbate, Sodium Benzoate.

PRINCIPAL DISPLAY PANEL

Fresh Protect
99.9% Natural
Skin Sanitizer Foam
Kills 99.99% of Germs
No Alcohol
7.5 fl. oz. (222 ml)

PRINCIPAL DISPLAY PANEL Fresh Protect Skin Sanitizer Foam 7.5 fl. oz. (222 ml)

FRESH PROTECT SKIN SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20802-1501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PUMMELO (UNII: ET1TN5W71X)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
AVENA SATIVA LEAF (UNII: 206PI19V7R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20802-1501-150 mL in 1 BOTTLE
2NDC:20802-1501-2222 mL in 1 BOTTLE
3NDC:20802-1501-3800 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A12/16/2010
FRESH PROTECT SKIN SANITIZER 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20802-1503
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PUMMELO (UNII: ET1TN5W71X)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
AVENA SATIVA LEAF (UNII: 206PI19V7R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20802-1503-13785 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: f3475182-3cd1-44b2-be07-cbcb554f4b55
Set id: 3497550b-2622-494c-a7c5-d5b0399e5fb1
Version: 3
Effective Time: 20110102
 
Omega Tech Labs Inc.