Label: STERITE ELEMENT- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 81576-2000-2 - Packager: PALVI MEXICO, S.A. DE C.V.
- 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 February 16, 2021
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- ACTIVE INGREDIENT SECTION
- PURPOSE SECTION
- INDICATIONS AND USAGE SECTION
- DOSAGE AND ADMINISTRATION SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
- WARNINGS AND PRECAUTIONS SECTION
- WARNINGS SECTION
- STOP USE SECTION
- INACTIVE INGREDIENTS
- PACKAGE LABEL PRINCIPAL DISPLAY
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INGREDIENTS AND APPEARANCE
STERITE ELEMENT
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81576-2000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.002 mg in 1 mL DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE 0.006 mg in 1 mL Inactive Ingredients Ingredient Name Strength ACID GREEN 50 (UNII: 9B7E8Y9D0X) 0.0105 mL in 1 mL EDETATE DISODIUM (UNII: 7FLD91C86K) 0.0003 mL in 1 mL LEMON OIL (UNII: I9GRO824LL) 0.003 mL in 1 mL SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.005 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.9482 mL in 1 mL N-NONYLPHENOL (MIXED ISOMERS) (UNII: 79F6A2ILP5) 0.025 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81576-2000-2 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/16/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/16/2021 Labeler - PALVI MEXICO, S.A. DE C.V. (824338511) Registrant - PALVI MEXICO, S.A. DE C.V. (824338511) Establishment Name Address ID/FEI Business Operations PALVI MEXICO, S.A. DE C.V. 824338511 manufacture(81576-2000)
