FDA Label for Povidone-iodine Topical Antiseptic
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- STOP USE AND ASK A DOCTOR
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - SWABSTICK SINGLES POUCH
- PRINCIPAL DISPLAY PANEL - SWABSTICK SINGLES BOX
- PRINCIPAL DISPLAY PANEL - SWABSTICK TRIPLES BOX
- PRINCIPAL DISPLAY PANEL - PREP PADS, MEDIUM BOX
- PRINCIPAL DISPLAY PANEL - PREP PAD BULK CASE
- PRINCIPAL DISPLAY PANEL - PREP SOLUTION BOTTLE
- PRINCIPAL DISPLAY PANEL - PREP SOLUTION LABEL
Povidone-iodine Topical Antiseptic Product Label
The following document was submitted to the FDA by the labeler of this product Medline Industries, Inc.. 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% (equivalent to 1% available iodine)
Purpose
First Aid Antiseptic
Uses
- Healthcare antiseptic for preparation of the skin prior to surgery
- First aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Warnings
For external use only.
Do Not Use
- in the eyes
- longer than 1 week unless directed by a doctor
- on individuals who are allergic or sensitive to iodine
- or apply over large areas of the body
Stop Use And Ask A Doctor
- if irritation and redness develop
- if condition persists for more than 72 hours
- in case of deep or puncture wounds, animal bites or serious burns
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Clean the affected area.
- For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
- For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Other Information
Protect from freezing. Avoid excessive heat.
Inactive Ingredients
Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.
Questions
1-800-MEDLINE
Principal Display Panel - Swabstick Singles Pouch
NDC53329-945-09
Medline
Antiseptic
Povidone-Iodine, USP
Swabsticks, Singles
MDS093901
latex free
For professional and hospital use.
Contents: 1 Swabstick
Principal Display Panel - Swabstick Singles Box
NDC: 53329-945-29
Medline
Antiseptic
Povidone-Iodine, USP
Swabsticks, Singles
MDS093901
Discard appropriately after single use.
Protect from Freezing. Avoid excessive heat. For external use only.
latex free
Contents: 50 Each
Principal Display Panel - Swabstick Triples Box
NDC 53329-946-75
Medline
Antiseptic
Povidone-Iodine, USP
Swabsticks, Triples
MDS093902
Discard appropriately after single use.
Protect from freezing. Avoid excessive heat. For external use only.
latex free
Contents: 25 Pouches
Principal Display Panel - Prep Pads, Medium Box
Medline
Antiseptic
Povidone Iodine Prep Pads, Medium
MDS093917
For hospital and professional use.
Contents: 100 Pads
Principal Display Panel - Prep Pad Bulk Case
Povidone Iodine
Prep PADS
Medium Bulk
MDS093918
Contents: 3,000 Each Per Case
Principal Display Panel - Prep Solution Bottle
NDC: 53329-939-13
MEDLINE
PVP Prep Solution
Topical Antiseptic
Povidone-Iodine 10%
MDS093940
latexfree
www.medline.com
Manufactured for: Medline Industries, Inc.
Mundelein, IL 60060 USA Made in USA
To Order Call: 1-800-MEDLINE
RB11CTR
2 FL OZ (59 mL)
Principal Display Panel - Prep Solution Label
N: 53329-900-55
Medline
Prep Solution
with
Spray Bottle
Topical Antiseptic
Microbicide
MDS093942
latex free
Do not reuse
2 FL OZ (59 mL)
NDC 53329-904-04
Medline
Prep Solution
with Spray Bottle
Povidone Iodine USP, 10% Topical Solution
MDS093934
Topical Antiseptic
4 FL Oz (118 ml)
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