BETADINE DRY POWDER- povidone-iodine aerosol, spray 
Atlantis Consumer Healthcare, Inc.

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BETADINE® Dry Powder Spray

5%Povidone-iodine

Drug Facts

Active ingredient

Povidone-iodine,5% (0.5% available iodine).

Purpose

First aidantiseptic

Uses

First aidto help prevent infection in minor

  • cuts
  • scrapes
  • burns

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.

Ask a doctor before use if you have

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop use and ask a doctor if

  • the condition persists or gets worse
  • you need to use this product for more than 1 week

Keep out of reachof children.
If swallowed, get medicalhelp or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Isobutane,isopropyl myristate, pentrane, propane

Dist. by: AvrioHealth L.P. Stamford, CT 06901-3431
305653-0A

BetadineDry Powder Spray
NDC: 67618-165-01

Betadine Dry Powder Spray
BETADINE DRY POWDER 
povidone-iodine aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-165
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE.05 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE (UNII: BXR49TP611)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPANE (UNII: T75W9911L6)  
METHOXYFLURANE (UNII: 30905R8O7B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-165-0156.7 mL in 1 CAN; Type 0: Not a Combination Product06/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00306/15/2020
Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
Registrant - Atlantis Consumer Healthcare, Inc. (118983925)

Revised: 12/2023
Document Id: a3cb4462-d000-4159-bb26-678d8c7280c3
Set id: 1888546e-893e-132d-72b4-d138e71a2a8c
Version: 5
Effective Time: 20231222
 
Atlantis Consumer Healthcare, Inc.