Label: INDUSTRIAL SANITIZING- benzethonium chloride and dimethicone lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 59555-902-04, 59555-902-07, 59555-902-08, 59555-902-10, view more59555-902-11, 59555-902-13 - Packager: R&R Lotion, 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 December 8, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label
-
INGREDIENTS AND APPEARANCE
INDUSTRIAL SANITIZING
benzethonium chloride and dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-902 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride 2 mg in 1 mL Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Stearyl Alcohol (UNII: 2KR89I4H1Y) cholecalciferol (UNII: 1C6V77QF41) Cetyl Alcohol (UNII: 936JST6JCN) vitamin A (UNII: 81G40H8B0T) Behentrimonium Methosulfate (UNII: 5SHP745C61) Cetostearyl Alcohol (UNII: 2DMT128M1S) .Alpha.-Tocopherol (UNII: H4N855PNZ1) Ethylhexyl Palmitate (UNII: 2865993309) Gluconolactone (UNII: WQ29KQ9POT) Sodium Benzoate (UNII: OJ245FE5EU) Calcium Gluconate (UNII: SQE6VB453K) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-902-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:59555-902-04 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:59555-902-10 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 4 NDC:59555-902-11 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 5 NDC:59555-902-13 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 6 NDC:59555-902-07 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 12/21/2015 Labeler - R&R Lotion, Inc. (062979000)