Label: TOTAL SOLUTIONS HYGIEN HAND- benzalkonium soap
- NDC Code(s): 62819-268-01, 62819-268-02
- Packager: Athea Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 26, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- 62819-268-01.jpg
- 62819-268-02.jpg
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INGREDIENTS AND APPEARANCE
TOTAL SOLUTIONS HYGIEN HAND
benzalkonium soapProduct 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)
