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  5. Label Information: Aplicare Povidone-iodine Triples

FDA Label for Aplicare Povidone-iodine Triples

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF INJURIES ARE
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - WHEN USING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. STORAGE AND HANDLING
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. OTC - QUESTIONS
    15. PRINCIPAL DISPLAY PANEL - 3 SWABSTICK PACKET

Aplicare Povidone-iodine Triples 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


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

Otc - When Using



Avoid pooling beneath patient


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.


Storage And Handling



Avoid excessive heat. Store at room temperature.


Directions



apply locally as needed


Other Information



  • 1% titratable iodine
  • not made with natural rubber latex
  • for hospital or professional use only
  • for single 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 - 3 Swabstick Packet



NDC 52380-5101-3

NPN 02076101

APLICARE

◀  Tear Here    Hold Upright    Tear Here  ▶

THREE
POVIDONE-IODINE
SWABSTICKS

ANTISEPTIC
Non-Sterile Solution

Three 4-inch Saturated Swabsticks

Reorder No. S-3111

PRINCIPAL DISPLAY PANEL - 3 Swabstick Packet - aplicare 01

PRINCIPAL DISPLAY PANEL - 3 Swabstick Packet - aplicare 01


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