The following Structured Product Label (SPL) was submitted to the FDA by Great North, Llc, Dba Bernard Jensen Products for the product Bernard Jensens Povdine (NDC 79994-001). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dilute with equal parts water before use.
Sealed with a tamper-evident cap for your protection. If ring band is detached from cap or missing, do not use.
Distributed by:
Bernard Jensen Products
Chula Vista, CA 91911
www.bernardj.com
Made in Mexico
Active ingredient (before dilution)
Povidone-iodine 1%
Purpose
Antiseptic gargle
Use
first aid to help prevent the risk of infection in minor cuts and scrapes caused by dental procedures or accidental injury
Warnings
Do not use for more than 7 days unless directed by a dentist or doctor
Stop use and ask a dentist or doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If more than used for gargling is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years and older:
Children under 12 years: do not use
Other information
Inactive ingredients. glycerin, menthol, ethyl alcohol (6%), sodium hydroxide, purified water
Questions? (800) 755-4027
Bernard Jensen's
PovDine™
GARGLE SOLUTION
ORAL ANTISEPTIC
1% Povidone-Iodine Concentrated Solution
Mint Flavor
1 fl oz (30 ml)
* Please review the disclaimer below.
