FDA Label for Saninta 10% Povidone-iodine
View Indications, Usage & Precautions
Saninta 10% Povidone-iodine Product Label
The following document was submitted to the FDA by the labeler of this product Lernapharm. 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.
Active Ingredient
Povidone-Iodine 10% w/v
Purpose
Antiseptic
Use
Antiseptic skin preparation. Helps reduce bacteria that potentially can cause skin infection.
Warnings
For external use only.
Do Not Use
Do not use
- if allergic to iodine
- in the eyes
Stop Use And Ask A Doctor
Stop use and ask a doctorif
- injuries are deep puncture wounds or serious burns
- redness, irritation, swelling or pain persists or increases
- infection occurs
Avoid Pooling Beneath Patient
Avoid pooling beneath patient
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean the area.
- apply locally as needed
Other Information
- 1% titratable iodine
- not made with natural rubber latex
- for hospital or professional use only
- Store at room temperature between 59-86°F (15 - 30°C).
- Avoid freezing and excessive heat above 40°C (104°F).
Inactive Ingredients
Citric Acid, Glycerol, Nonoxynol-9, Purified Water USP, Sodium Hydroxide, Sodium Phosphate Dibasic
Questions Or Comments?
Questions or Comments? Tel.: 1-866-322-4634, weekdays between 8:00 am and 4:00 pm EST
Package Label - Principal Display Panel
NDC: 68356-601-01 / 68356-601-601-02
Product # 601-01 / 601-02
Hold upright
[Tear here and pour]
[Three 4-inch antiseptic swabsticks impregnated with 10% W/V povidone-iodine solution]
[Tear open]
Saninta
Antiseptic Solution
10% w/v Povidone-Iodine Solution
10% Povidone-Iodine
[0.75 Fl. oz (22.5 mL)]
Do Not Reuse
multiple-use cross-through logo
UPC Code
Manufactured by:
Lernapharm (LORIS) Inc.
2323 HALPERN, MONTREAL
QUEBEC, CANADA H4S 1S3
Made in Canada
LOT #: XXXX
EXP.: MM/YYYY
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