Active Ingredient
Povidone-Iodine 10% w/v
Saninta 10% Povidone-iodine Liquid
FDA Label NDC 81351-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ll Pharma for the product Saninta 10% Povidone-iodine (NDC 81351-004). 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 active ingredient, purpose, use, warnings, do not use, stop use and ask a doctor, avoid pooling beneath patient, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.: 1-833-336-6159
Package Label - Principal Display Panel
NDC: 81351-004-01 / 81351-004-02
Product # 004-01 / 004-02
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]
[0.75 Fl.ox (22.5 mL)]
Latex cross-through logo
multiple-use cross-through logo
UPC Code
Manufactured by:
LL Pharma Inc.
5789 rue Cypihot, Saint-Laurent, Quebec H4S 1R3
Made in Canada
www.llpharmainc.com
LOT #: XXXX
EXP.: MM/YYYY
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