BETADINE DRY POWDER- povidone-iodine aerosol, spray

Betadine Dry Powder by

Drug Labeling and Warnings

Betadine Dry Powder by is a Otc medication manufactured, distributed, or labeled by Avrio Health L.P., Purdue Pharma LP, TRI-PAC, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Clean the affected area
• SHAKE WELL BEFORE USE
• Hold can approximately 6 inches from wound and apply a thinlayer over affected area 1 to 3 daily
• May be covered with a sterile bandage

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)

Inactive ingredients

Isobutane,isopropyl myristate, pentrane, propane

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

BetadineDry Powder Spray
NDC: 67618-165-01

INGREDIENTS AND APPEARANCE

BETADINE DRY POWDER 
povidone-iodine aerosol, spray

Product 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)