FDA Label for Bernard Jensens Povdine
View Indications, Usage & Precautions
Bernard Jensens Povdine Product Label
The following document was submitted to the FDA by the labeler of this product Great North, Llc, Dba Bernard Jensen Products. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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
Otc - Active Ingredient
Active ingredient (before dilution)
Povidone-iodine 1%
Otc - Purpose
Purpose
Antiseptic gargle
Indications & Usage
Use
first aid to help prevent the risk of infection in minor cuts and scrapes caused by dental procedures or accidental injury
Warnings
Warnings
Otc - Do Not Use
Do not use for more than 7 days unless directed by a dentist or doctor
Otc - Stop Use
Stop use and ask a dentist or doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
Directions
Adults and children 12 years and older:
- dilute 1 tablespoon (15 ml) of product with equal amount of water
- rinse and gargle for 30 seconds, then spit out. Do not swallow solution or rinse mouth afterward
- use up to four times daily for no more than 7 days
Children under 12 years: do not use
Storage And Handling
Other information
- store at room temperature
- may stain clothing, dentures and braces
- avoid contact with jewelry, especially silver
Inactive Ingredient
Inactive ingredients. glycerin, menthol, ethyl alcohol (6%), sodium hydroxide, purified water
Otc - Questions
Questions? (800) 755-4027
Package Label.Principal Display Panel
Bernard Jensen's
PovDine™
GARGLE SOLUTION
ORAL ANTISEPTIC
1% Povidone-Iodine Concentrated Solution
Mint Flavor
1 fl oz (30 ml)
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