POVIDONE IODINE - povione iodine ointment 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

drug facts


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









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








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.






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




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.




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





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



Carton
carton


POVIDONE IODINE 
povione iodine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE1 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-085-991 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/30/2008
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: e77febb7-201f-4252-85f3-c7d6908373fe
Set id: 972b23c5-cb8b-4513-8f69-44b50d767c00
Version: 11
Effective Time: 20110204
 
CVS Pharmacy