POVIDONE IODINE- povione iodine ointment

POVIDONE IODINE by

Drug Labeling and Warnings

POVIDONE IODINE by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Section from Tube Label Follows:

Active Ingredient                                                Purpose
Povidone iodine 10%
(available iodine 1%) ............................First aid antiseptic




Section from Carton Label Follows:

Active ingredient                                                                   Purpose
Povidone iodine 1% (available iodine 1%)........................................First aid antiseptic

PURPOSE

Section from Tube Label Follows:

Active Ingredient                                                Purpose
Povidone iodine 10%
(available iodine 1%) ............................First aid antiseptic

Uses first aid to help prevent infection in

- minor cuts   - scrapes    - burns






Section from Carton Label Follows:

Active ingredient                                                                   Purpose
Povidone iodine 1% (available iodine 1%)........................................First aid antiseptic

Uses
first aid to help prevent infection in  - minor cuts   - scrapes   - burns

KEEP OUT OF REACH OF CHILDREN

Section from Warnings portion of tube label follows:

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



Section from Warnings section of Carton label follows:

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

INDICATIONS & USAGE

Section from Directions portion of tube label follows:

Directions - clean the affected area and dry thoroughly
- apply a small amount of this product on the area 1 to 3 times
daily - May be covered with a sterile bandage


Section from Directions portion of carton label follows:

Directions
- clean the affected area and dry thoroughly
- apply a small amount of this product on the area 1 to 3 times daily
- May be covered with a sterile bandage

WARNINGS

From Warnings Section of Tube Label:

Warnings For external use only. Do not use - In the eyes
- over large areas of the body - longer than 1 week unless
directed by a doctor. Ask a doctor before use - in case of deep
or puncture wounds, animal bites, or serious burns. Stop use
and ask a doctor if - condition persists or gets worse. Keep
out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away.


From Warnings Section of Carton Label:

Warnings
For external use only.
Do not use - In the eyes  - over large areas of the body
- longer than 1 week unless directed by a doctor.
Ask a doctor before use - in case of deep or puncture wounds, animal bites, or serious burns.
Stop use and ask a doctor if - condition persists or gets worse.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control
Center right away.

DOSAGE & ADMINISTRATION

Section from Directions portion of tube label follows:

Directions - clean the affected area and dry thoroughly
- apply a small amount of this product on the area 1 to 3 times
daily - May be covered with a sterile bandage


Section from Directions portion of carton label follows:

Directions
- clean the affected area and dry thoroughly
- apply a small amount of this product on the area 1 to 3 times daily
- May be covered with a sterile bandage

INACTIVE INGREDIENT

From Inactive Ingredients section of Tube Label:

Inactive Ingredients PEG-75, PEG-8, purified water


From Inactive Ingredients section of Carton Label:

Inactive Ingredients PEG-75, PEG-8, purified water

PRINCIPAL DISPLAY PANEL

Carton

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povione iodine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-085
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)	2.5 g  in 10 g
WATER (UNII: 059QF0KO0R)	0.5 g  in 10 g
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	6 g  in 10 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-085-99	1 in 1 CARTON
1		28.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/30/2008

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture