Label: STERITE PLUS- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 81576-1000-2 - 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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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- OTC PURPOSE SECTION
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- WARNINGS AND PRECAUTIONS SECTION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT SECTION
- PACKAGE LABEL SECTION
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INGREDIENTS AND APPEARANCE
STERITE PLUS
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81576-1000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.0006 mg in 1 mL DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE 0.0018 mg in 1 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) 0.0003 mL in 1 mL N-NONYLPHENOL (MIXED ISOMERS) (UNII: 79F6A2ILP5) 0.007 mL in 1 mL WATER (UNII: 059QF0KO0R) 0.99 mL in 1 mL LEMON OIL (UNII: I9GRO824LL) 0.0002 mL in 1 mL ACID GREEN 50 (UNII: 9B7E8Y9D0X) 0.0001 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81576-1000-2 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(81576-1000)
