FRESH PROTECT SKIN SANITIZER- benzalkonium chloride spray
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 Spray

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 Spray
Kills 99.99% of Germs
No Alcohol
8 fl. oz. (237 ml)

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

FRESH PROTECT SKIN SANITIZER
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:20802-1502
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.001 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:20802-1502-1	89 mL in 1 BOTTLE, SPRAY
2	NDC:20802-1502-2	237 mL in 1 BOTTLE, SPRAY

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

Labeler - Omega Tech Labs Inc. (019313817)

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