TOTAL SOLUTIONS HYGIEN HAND- benzalkonium soap

Total Solutions Hygien Hand by

Drug Labeling and Warnings

Total Solutions Hygien Hand 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 help reduce bacteria on 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

Do not use in the eyes

WHEN USING

When using this product do not get into eyes. If contact occurs, rinse thoroughly with
water.

STOP USE

Stop use and ask a doctor if irritation and redness develop. If condition persists for more
than 72 hours consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control
Center right away.

Directions

■ Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and
forearms. Scrub hands thoroughly. Rinse with water and repeat.

Other information

■ Store in a cool, dry place.

Inactive ingredients

Water, Poloxamer 124, Lauramidopropylamine Oxide; PEG-3 Cocamide, Hydroxyethylcellulose, Glycerin, Myristamidopropylamine oxide, Benzyl Alcohol, Fragrance, Phenoxyethanol, Citric Acid, FD&C Yellow Number 5, FD&C Red Number 40.

62819-268-01.jpg

62819-268-02.jpg

INGREDIENTS AND APPEARANCE

TOTAL SOLUTIONS HYGIEN HAND 
benzalkonium soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62819-268
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
WATER (UNII: 059QF0KO0R)	89.26 mL  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.0003 g  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.0006 g  in 100 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.05 g  in 100 mL
POLOXAMER 124 (UNII: 1S66E28KXA)	4 mL  in 100 mL
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)	2.1 mL  in 100 mL
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)	0.7 mL  in 100 mL
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)	1.5 mL  in 100 mL
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)	1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.8 mL  in 100 mL
BENZYL ALCOHOL (UNII: LKG8494WBH)	0.4 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.072 mL  in 100 mL

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62819-268-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/18/2013
2	NDC: 62819-268-02	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/18/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/18/2013

Labeler - Athea Laboratories, Inc. (078281547)