TOTAL SOLUTIONS HYGIEN HAND- benzalkonium soap 
Athea Laboratories, 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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Total Solutions Hygien Hand Soap

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 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
than 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 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.

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TOTAL SOLUTIONS HYGIEN HAND 
benzalkonium soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62819-268
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62819-268-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/18/2013
2NDC:62819-268-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/18/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/18/2013
Labeler - Athea Laboratories, Inc. (078281547)

Revised: 1/2022
Document Id: d685553c-a151-1efe-e053-2a95a90a4512
Set id: fcd63fe4-a357-4432-a738-ae1bccbb8bae
Version: 3
Effective Time: 20220126
 
Athea Laboratories, Inc.