Label: POVIDONE IODINE- povione iodine ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-085-99 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated February 4, 2011
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- Official Label (Printer Friendly)
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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
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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
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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.
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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
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
POVIDONE IODINE
povione iodine ointmentProduct 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
