Label: YOUR LOGO HERE BURN FIRST AID- benzocaine, benzethonium chloride, and menthol aerosol, spray
- NDC Code(s): 52982-101-01, 52982-101-03
- Packager: Dixon Investments, Inc.
- Category: HUMAN OTC DRUG LABEL
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 9, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask doctor if
- Keep out of reach of children
- Directions
- Inactive Ingredient
- Principal Display
-
INGREDIENTS AND APPEARANCE
YOUR LOGO HERE BURN FIRST AID
benzocaine, benzethonium chloride, and menthol aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52982-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 8500 mg in 85 g BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 170 mg in 85 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 281 mg in 85 g Inactive Ingredients Ingredient Name Strength DIPROPYLENE GLYCOL (UNII: E107L85C40) ISOBUTANE (UNII: BXR49TP611) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52982-101-03 85 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/05/2013 2 NDC:52982-101-01 14.2 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/05/2013 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(52982-101)