Label: I.C. SANITIZER AND RE-MOISTURIZER WITH BENZALKONIUM CHLORIDE- benzalkonium chloride lotion
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NDC Code(s):
59555-903-03,
59555-903-04,
59555-903-06,
59555-903-08, view more59555-903-09, 59555-903-10, 59555-903-11, 59555-903-16
- Packager: R & R Lotion, Inc
- Category: HUMAN OTC DRUG LABEL
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 May 9, 2022
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
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Ingredients
Purified Water, Cetearyl Alcohol (and) Behentrimonium Methosulfate, Glyceryl Stearate (and) PEG-100 Stearate, C/C Triglyceride, Sunflower Butter, Glycerin, Dimethicone, Cetyl Alcohol, Hydrolyzed Jojoba Esters, Gluconolactone (and) Sodium Benzoate, Shea Butter, Xanthan Gum, Disodium EDTA, Propylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit, Coffea Robusta Seed, Fragaria Vesca (Strawberry) Fruit, Euterpe Oleracea Fruit, Vaccinium Angustifolium (Blueberry) Fruit, Camellia Sinensis (Green Tea) Leaf, Vitis Vinifera (Grape) Seed, Punica (Pomegranate) Granatum Fruit, Rubus Idaeus (Raspberry) Fruit, Potassium Sorbate, Agave Tequilana Leaf (Blue Agave), Simmondsia Chinensis (Jojoba) Seed, Aloe Barbadensis Leaf Juice (Aloe Vera), Vitamin E Acetate, Vitamin A (and) D
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- PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
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INGREDIENTS AND APPEARANCE
I.C. SANITIZER AND RE-MOISTURIZER WITH BENZALKONIUM CHLORIDE
benzalkonium chloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-903 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) Calcium Gluconate (UNII: SQE6VB453K) Sodium Benzoate (UNII: OJ245FE5EU) Gluconolactone (UNII: WQ29KQ9POT) Behentrimonium Methosulfate (UNII: 5SHP745C61) Cetostearyl Alcohol (UNII: 2DMT128M1S) Glyceryl 1-Stearate (UNII: 258491E1RZ) Dimethicone (UNII: 92RU3N3Y1O) PEG-100 Stearate (UNII: YD01N1999R) Cetyl Alcohol (UNII: 936JST6JCN) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Shea Butter (UNII: K49155WL9Y) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Glycerin (UNII: PDC6A3C0OX) POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62) CHOLECALCIFEROL (UNII: 1C6V77QF41) vitamin A (UNII: 81G40H8B0T) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-903-03 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/02/2018 2 NDC:59555-903-04 59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 11/02/2018 3 NDC:59555-903-09 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/02/2018 4 NDC:59555-903-08 236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 11/02/2018 5 NDC:59555-903-10 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/02/2018 6 NDC:59555-903-11 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/02/2018 7 NDC:59555-903-06 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/02/2018 8 NDC:59555-903-16 4 mL in 1 PACKET; Type 0: Not a Combination Product 05/05/2022 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)