Label: YOUR LOGO HERE POISON IVY FIRST AID- benzethonium chloride and benzocaine aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 52982-107-03 - Packager: Dixon Investments, 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 April 9, 2013
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask a doctor
- Keep out of reach of children
- Directions
- Other Information
- Inactive Ingredients
- Principal Display
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INGREDIENTS AND APPEARANCE
YOUR LOGO HERE POISON IVY FIRST AID
benzethonium chloride and benzocaine aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52982-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 4250 mg in 85 g BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 127.5 mg in 85 g Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PVP/VA COPOLYMER (UNII: D9C330MD8B) ALCOHOL (UNII: 3K9958V90M) BUTANE (UNII: 6LV4FOR43R) PROPANE (UNII: T75W9911L6) ISOBUTANE (UNII: BXR49TP611) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52982-107-03 85 g in 1 BOTTLE, SPRAY 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(52982-107)