FDA Label for Aplicare Povidone-iodine
View Indications, Usage & Precautions
Aplicare Povidone-iodine Product Label
The following document was submitted to the FDA by the labeler of this product Aplicare Products, Llc. 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
For external use only
Avoid pooling beneath patient
Active Ingredient
Povidone-iodine USP 10%
Purpose
Antiseptic
Use
antiseptic skin preparation
Do Not Use
- if allergic to iodine
- in the eyes
Ask A Doctor Before Use If Injuries Are
- deep or puncture wounds
- serious burns
Stop Use And Ask A Doctor If
- redness, irritation, swelling or pain persists or increases
- infection occurs
Storage And Handling
Avoid excessive heat. Store at room temperature.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Directions
apply locally as needed
Other Information
- 1% titratable iodine
- not made with natural rubber latex
- for hospital or professional use only
Inactive Ingredients
citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
Otc - Questions
For questions, comments, or to report serious side effects:
800-760-3236
Monday-Friday 8:30 a.m.-5:00 p.m. EST
Principal Display Panel - 30 Ml Solution Packet
NDC 52380-0011-1
NPN 02076144
TEAR HERE
POUR
APLICARE
ONE FLUID OUNCE
POVIDONE-IODINE
SOLUTION
ANTISEPTIC
Non-Sterile Solution
1 Fl. oz. (30 mL)
Reorder No. L-1011
* Please review the disclaimer below.