Label: ANTISEPTIC FIRST AID- benzalkonium chloride and benzocaine spray
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Contains inactivated NDC Code(s)
NDC Code(s): 0924-0931-01 - Packager: Acme United Corp
- 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 October 6, 2014
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
ANTISEPTIC FIRST AID
benzalkonium chloride and benzocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0931 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:0924-0931-01 107 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/06/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/06/2014 Labeler - Acme United Corp (001180207) Registrant - Safetec of America, Inc (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc 874965262 MANUFACTURE(0924-0931)