Label: APLICARE POVIDONE-IODINE PAINT- povidone-iodine solution
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated June 1, 2017
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
Stop use and ask a doctor if
- redness, irritation, swelling or pain persists or increases
- infection occurs
Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 2 Sponge Sticks Packet
INGREDIENTS AND APPEARANCE
APLICARE POVIDONE-IODINE PAINT
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-4011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM HYDROXIDE (UNII: 55X04QC32I) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52380-4011-2 2 mL in 1 PACKET; Type 0: Not a Combination Product 05/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/31/2017 Labeler - Aplicare, Inc. (107255002) Establishment Name Address ID/FEI Business Operations Aplicare, Inc. 107255002 manufacture(52380-4011)