BETADINE SOLUTION- povidone-iodine solution

Betadine by

Drug Labeling and Warnings

Betadine by is a Otc medication manufactured, distributed, or labeled by Atlantis Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Purpose

First aid antiseptic

Uses

First aid to helpprevent infection in minor

• cuts
• scrapes
• burns

WarningsFor external use only

Do not use

• in the eyes
• over large areas of the body
• if you are allergic to povidone-iodine or any other ingredientsin this preparation

Ask a doctor before useif 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 REACH OF CHILDREN

Keep out of reach of children.
If swallowed, getmedical help or contact a Poison Control Center right away

Directions

• clean the affected area
• apply a small amount of product to the area 1 to 3 timesdaily
• may be covered with a sterile bandage
• if bandaged, let dry first

Other information

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

Inactive ingredients

citric acid, disodiumphosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

SPL UNCLASSIFIED SECTION

Dist.by:
Avrio Health L.P.
Stamford, CT 06901-3431

305541-0D

PRINCIPAL DISPLAY PANEL

BetadineSolution 6 fl oz Bottle
NDC: 67618-150-18

BetadineSolution 8 fl oz Bottle
NDC: 67618-150-08

INGREDIENTS AND APPEARANCE

BETADINE  SOLUTION
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-150-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980
2	NDC: 67618-150-18	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/01/1980

Labeler - Atlantis Consumer Healthcare, Inc. (118983925)

Registrant - Atlantis Consumer Healthcare, Inc. (118983925)