Label: NOVANA WASH PERINEAL SKIN CLEANSER- benzethonium chloride solution
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Contains inactivated NDC Code(s)
NDC Code(s): 76077-100-04 - Packager: NOVANA MEDICAL LLC
- 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 April 4, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NOVANA WASH PERINEAL SKIN CLEANSER
benzethonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76077-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride 0.001 mL in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sodium Laureth Sulfate (UNII: BPV390UAP0) POLYQUATERNIUM-7 (76/24 ACRYLAMIDE/DADMAC; 120 KD) (UNII: AAJ238UT03) Phenoxyethanol (UNII: HIE492ZZ3T) Iodopropynyl Butylcarbamate (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76077-100-04 120 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/04/2012 Labeler - NOVANA MEDICAL LLC (964916600) Registrant - O.L. PRODUCTS, INC. (961405883) Establishment Name Address ID/FEI Business Operations O.L. PRODUCTS, INC. 961405883 label, manufacture