Label: BETADINE DRY POWDER- povidone-iodine aerosol, spray
- NDC Code(s): 67618-165-01
- Packager: Atlantis Consumer Healthcare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 22, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
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Warnings For external use only
Extremely Flammable Do not use near heat, flame or while smoking. Do notpuncture or incinerate. Contents under pressure. Do not store at temperaturesabove 120⁰F. Intentional misuse by deliberately concentrating andinhaling the contents can be harmful or fatal
Do not use
- in or near eyes
- over large areas of the body
- if you are allergic to povidone-iodine or any other ingredientsin this preparation
When using this product
- do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BETADINE DRY POWDER
povidone-iodine aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-165 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE .05 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PROPANE (UNII: T75W9911L6) METHOXYFLURANE (UNII: 30905R8O7B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67618-165-01 56.7 mL in 1 CAN; Type 0: Not a Combination Product 06/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 06/15/2020 Labeler - Atlantis Consumer Healthcare, Inc. (118983925) Registrant - Atlantis Consumer Healthcare, Inc. (118983925)