Aplicare povidone iodine swabstick solution

Spl unclassified section

Drug Facts

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

antiseptic skin preparation

Warnings

For external use only

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 - keep out of reach of children section

Keep out of reach of children.In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Storage and handling section

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

Inactive ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Otc - questions section

For questions, comments, or to report serious side effects:
800-760-3236
Monday-Friday
8:30 a.m.- 5:00 p.m. EST

Ingredients and appearance - Product information

Aplicare povidone iodine swabstick solution- Povidone-iodine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 52380-4101
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Povidone-iodine ( UNII: 85H0HZU99M)( Iodine - UNII: 9679TC07X4 ) 10 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Sodium phosphate, dibasic ( UNII: GR686LBA74)
Ammonium nonoxynol-4 sulfate ( UNII: 9HIA70O4J0)
Sodium hydroxide ( UNII: 55X04QC32I)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 52380-4101-1 2mL in 1 PACKET 2017/05/31

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part333A USA 2017/05/31

Labeler - Aplicare Products, LLC( 081054904)

Establishment

Name ID/FEI Business Operations
Aplicare Products, LLC 081054904 manufacture( 52380-4101)

Principal display panel - 1 swabstick packet

NDC 52380-4101-1

NPN 02076101

APLICARE

ONE
POVIDONE-IODINE
SWABSTICK

ANTISEPTIC
Non-Sterile Solution

One 4-inch saturated swabstick

Reorder No. S-1111