Label: FIRST AID ANTISEPTIC- benzalkonium chloride and benzocaine spray
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Contains inactivated NDC Code(s)
NDC Code(s): 49314-0098-1 - Packager: Unishield
- 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 27, 2015
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INGREDIENTS AND APPEARANCE
FIRST AID ANTISEPTIC
benzalkonium chloride and benzocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-0098 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 g benzocaine (UNII: U3RSY48JW5) (benzocaine - UNII:U3RSY48JW5) benzocaine 50 mg in 1 g 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:49314-0098-1 59 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/27/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/27/2015 Labeler - Unishield (790677053) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc 874965262 MANUFACTURE(49314-0098)