Label: I.C. BARRIER- benzethonium chloride and dimethicone lotion/shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 59555-601-04, 59555-601-08, 59555-601-10, 59555-601-11 - 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 September 17, 2014
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- PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
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INGREDIENTS AND APPEARANCE
I.C. BARRIER
benzethonium chloride and dimethicone lotion/shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-601 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) .Alpha.-Tocopherol (UNII: H4N855PNZ1) Ethylhexyl Palmitate (UNII: 2865993309) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-601-08 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:59555-601-04 60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:59555-601-10 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 4 NDC:59555-601-11 3785 mL in 1 BOTTLE, PUMP; 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 09/17/2014 Labeler - R&R Lotion, Inc. (062979000)