Label: YOUR LOGO HERE ANTISEPTIC FIRST AID- benzalkonium chloride and lidocaine spray, metered
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Contains inactivated NDC Code(s)
NDC Code(s): 52982-120-12, 52982-120-13 - Packager: Dixon Investments, 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 May 31, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purposes
- Uses
- Warnings
- Do not use
- Stop use and ask a doctor if
- Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
- Directions
- Inactive Ingredients
- Principal Display
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INGREDIENTS AND APPEARANCE
YOUR LOGO HERE ANTISEPTIC FIRST AID
benzalkonium chloride and lidocaine spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52982-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 1912.5 mg in 90 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 107.1 mg in 90 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52982-120-13 90 mL in 1 BOTTLE, SPRAY 2 NDC:52982-120-12 60 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/05/2013 Labeler - Dixon Investments, Inc. (115315822) Registrant - Dixon Investments, Inc. (115315822) Establishment Name Address ID/FEI Business Operations Dixon Investments, Inc. 115315822 manufacture(52982-120)
