Label: BURN WATER SOLUBLE- benzocaine, benzethonium chloride, menthol spray
NORTH BURN- benzocaine, benzethonium chloride, menthol spray
- NDC Code(s): 0498-0020-40, 0498-0021-40
- Packager: Honeywell Safety Products USA, 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 December 28, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Flammable
keep away from fire or flame
contents under pressure
do not puncture or incinerate container
do not expose to temperatures above 120 0 FDo not use
- in or near the eyes or other mucous membranes
- in case of serious burns
- in case of deep or puncture wounds
- for prolonged period of time
- on large portion of the body
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel
- Honeywell Burn Spray Water Soluble
-
INGREDIENTS AND APPEARANCE
BURN WATER SOLUBLE
benzocaine, benzethonium chloride, menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-0021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g in 100 g BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.33 g in 100 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:0498-0021-40 85 g in 1 CAN; Type 0: Not a Combination Product 11/12/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/12/2018 NORTH BURN
benzocaine, benzethonium chloride, menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-0020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 10 g in 100 g BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 0.2 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.33 g in 100 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:0498-0020-40 85 g in 1 CAN; 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 - Honeywell Safety Products USA, Inc (079287321) Registrant - Honeywell Safety Products USA, Inc (079287321)