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Package Insert and Label Information: Aplicare Povidone-iodine

By Aplicare, Inc. | Last revised: 21 September 2010

APLICARE POVIDONE-IODINE — povidone-iodine solution
Aplicare, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Povidone-iodine 10%

Antiseptic

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

Antiseptic skin preparation.

Do not use if allergic to iodine.

For external use only.

Ask a doctor if injuries are:

  • deep or puncture wounds
  • serious burns
Do not get in eyes.
Avoid “pooling” beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Apply locally as needed.

Disodium phosphate
Glycerin
Nonoxynol-10
Simethicone
Water

Povidone-iodine Ampule

Povidone-iodine AmpulePovidone-iodine Ampule
APLICARE POVIDONE-IODINE
povidone-iodine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-1721
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Povidone-iodine (Iodine) Povidone-iodine 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Nonoxynol-10
Glycerin
Sodium Phosphate, Dibasic
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52380-1721-1 0.65 g in 1 AMPULE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 09/01/1998
Labeler — Aplicare, Inc. (107255002)
Establishment
Name Address ID/FEI Operations
Aplicare, Inc. 058377631 manufacture

Revised: 09/2010 Aplicare, Inc.