TOTAL SOLUTIONS ALCOHOL-FREE HAND SANITIZING FOAM- benzalkonium liquid

Total Solutions Alcohol-Free Hand Sanitizing Foam by

Drug Labeling and Warnings

Total Solutions Alcohol-Free Hand Sanitizing Foam by is a Otc medication manufactured, distributed, or labeled by Athea Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.12%

Purpose

Antiseptic

Uses

• For handwashing to decrease bacteria on the skin.
• After changing diapers.
• After assisting ill persons.
• Before contact with a person under medical care or treatment.
• Recommended for repeat use.

Warnings

For external use only.

Do not use

in the eyes.

When using this product

do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation and redness develop. If condition persists for more that 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wet hands thoroughly with product and allow to dry.
• Children under six years of age should be supervised whtn using this product.

Other information

• Store in a cool, dry place.

Inactive ingredients

Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrance, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E).

1 gallon

INGREDIENTS AND APPEARANCE

TOTAL SOLUTIONS ALCOHOL-FREE HAND SANITIZING FOAM 
benzalkonium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62819-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62819-282-00	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/03/2011

Labeler - Athea Laboratories, Inc. (078281547)

Establishment
Name	Address	ID/FEI	Business Operations
Athea Laboratories, Inc.		006117816	label(62819-282) , manufacture(62819-282)