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| Product NDC Code | 68356-119 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Loris povidone-iodine solution |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LIQUID | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | LernaPharm Loris Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Povidone Iodine 10% w/v
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Clean the area. Apply product to the operative site prior to surgery. Apply with friction for 30 seconds. Do not blot or wipe away.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citric Acid, Glycerol, Nonoxynol-9, Purified Water, Sodium Hydroxide, Sodium Phosphate Dibasic
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Loris Povidone-Iodine Solution Povidone-Iodine SODIUM PHOSPHATE, DIBASIC POVIDONE-IODINE IODINE ANHYDROUS CITRIC ACID GLYCERIN NONOXYNOL-9 WATER SODIUM HYDROXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel Hold upright Product # 119-XXU NDC: 68356-119-XX Loris Povidone-Iodine [Solution] [TEAR OPEN] [Tear here and pour] [Three 4-inch antiseptic swabsticks impregnated with 10% W/V povidone iodine solution] [0.75 Fl. oz (22.5 mL)] Antiseptic Solution For hospital and professional use only MANUFACTURED BY LERNAPHARM (LORIS) INC. 2323 HALPERN, VILLE ST-LAURENT QUEBEC, CANADA H4S 1S3 image of 68356-119-01 image of 68356-119-02
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other Information Store at room temperature between 59-86 o F (15-30 o C). 1% titratable iodine. Latex free
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For External Use Only Do not use in the eyes. Discontinue use if irritation and redness develop. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API