BETADINE SKIN CLEANSER- povidone-iodine solution

Betadine Skin Cleanser by

Drug Labeling and Warnings

Betadine Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Purdue Products LP, Purdue Pharma LP, Thatcher Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredient

Povidone-iodine, 7.5% – equal to 0.75% available iodine

PURPOSE

Purpose

First aid antiseptic

INDICATIONS & USAGE

Uses

• disinfectant hand wash and skin cleanser
• significantly reduces bacteria on the skin

INDICATIONS & USAGE

Warnings
For external use only

Do not use this product

• in the eyes
• over large areas of the body
• If you are allergic to povidone-iodine or any other ingredients in this preparation
• Longer than 1 week unless directed by a doctor

DO NOT USE

Ask a doctor before use if you have

• deep or puncture wounds
• serious burns
• animal bites

STOP USE

Stop using this product and ask a doctor if

• redness, irritation, swelling, or pain continues or increases
• infection occurs

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

• wet skin and apply a sufficient amount for lather to cover all surfaces
• wash vigorously for at least 15 seconds
• rinse and dry thoroughly

HOW SUPPLIED

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

ammonium nonoxynol-4 sulfate, nonoxynol-9, purified water, sodium hydroxide

Dist. by:
Purdue Products L.P.
Stamford, CT 06901-3431

301011-0F

©2015, Purdue Products L.P.

DOSAGE FORMS & STRENGTHS

DOSAGE & ADMINISTRATION

WARNINGS

PRINCIPAL DISPLAY PANEL

Betadine Skin Cleanser
NDC: 67618-149-04

INGREDIENTS AND APPEARANCE

BETADINE SKIN CLEANSER 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-149-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1980	07/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/1980	07/01/2021

Labeler - Purdue Products LP (141916531)

Registrant - Purdue Pharma LP (932323652)

Establishment
Name	Address	ID/FEI	Business Operations
Thatcher Company		041307356	MANUFACTURE(67618-149)