Label: ANTISEPTIC- benzalkonium chloride, benzocaine spray
- NDC Code(s): 73598-0681-1
- Packager: JHK Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 25, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only. Flammable keep away from fire or flame.
Do not use
- near eyes or mucous membranes
- on deep or puncture wounds, animal bites or serious burns
- over large areas of the body
- more than one week unless directed by a doctor
- Directions
- Other Information
- Inactive ingredients
- Questions?
- 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:73598-0681 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride 100 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:73598-0681-1 59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/14/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M004 02/14/2020 Labeler - JHK Inc (867236309) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(73598-0681)