The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Povidone Iodine (NDC 59779-085). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Section from Tube Label Follows:Active Ingredient PurposePovidone iodine 10%(available iodine 1%) ............................First aid antisepticSection from Carton Label Follows:Active ingredient PurposePovidone iodine 1% (available iodine 1%)........................................First aid antiseptic
Otc - Purpose
Section from Tube Label Follows:Active Ingredient PurposePovidone iodine 10%(available iodine 1%) ............................First aid antisepticUses first aid to help prevent infection in- minor cuts - scrapes - burnsSection from Carton Label Follows:Active ingredient PurposePovidone iodine 1% (available iodine 1%)........................................First aid antisepticUsesfirst aid to help prevent infection in - minor cuts - scrapes - burns
Otc - 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 unlessdirected by a doctor. Ask a doctor before use - in case of deepor puncture wounds, animal bites, or serious burns. Stop useand ask a doctor if - condition persists or gets worse. Keepout of reach of children. If swallowed, get medical help orcontact 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 timesdaily - May be covered with a sterile bandageSection 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 waterFrom Inactive Ingredients section of Carton Label:Inactive Ingredients PEG-75, PEG-8, purified water
Package Label.Principal Display Panel
Carton
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