Label: ANTISEPTIC- benzalkonium chloride, benzocaine spray
- NDC Code(s): 51532-5300-3
- Packager: Afassco 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 January 12, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL – bottle label
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INGREDIENTS AND APPEARANCE
ANTISEPTIC
benzalkonium chloride, benzocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-5300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride 1 mg in 1 mL benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine 50 mg in 1 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:51532-5300-3 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/09/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/09/2012 Labeler - Afassco Inc. (609982723) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(51532-5300)