BETADINE SOLUTION- povidone-iodine solution

Betadine by

Drug Labeling and Warnings

Betadine by is a Otc medication manufactured, distributed, or labeled by Avrio Health L.P., Purdue Pharma LP, Humco Holding Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

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

PURPOSE

Purpose

First aid antiseptic

INDICATIONS & USAGE

Uses

First aid to help prevent infection in minor

• cuts
• scrapes
• burns

INDICATIONS & USAGE

Warnings For 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 ingredients in this preparation

DO NOT USE

Ask a doctor before use if you have

• deep or puncture wounds
• serious burns
• animal bites

STOP USE

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, get medical help or contact a Poison Control Center right away.

WHEN USING

Directions

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

HOW SUPPLIED

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

pareth 25-9, purified water, sodium hydroxide

Dist. by:
Arviro Health L.P.
Stamford, CT

303993-0B

DOSAGE FORMS & STRENGTHS

DOSAGE & ADMINISTRATION

WARNINGS

PRINCIPAL DISPLAY PANEL

Betadine Solution
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
C12-15 PARETH-9 (UNII: H3ZIY6WP1R)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-150-05	14.8 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980
2	NDC: 67618-150-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980
3	NDC: 67618-150-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980
4	NDC: 67618-150-09	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980
5	NDC: 67618-150-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980
6	NDC: 67618-150-17	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980
7	NDC: 67618-150-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980
8	NDC: 67618-150-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/1980

Labeler - Avrio Health L.P. (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Thatcher Company		041307356	MANUFACTURE(67618-150)