Label: APOTHECARY PVP TOPICAL- 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 February 12, 2016
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- Active ingredient
For external use only.
Do not use
- in the eyes
- longer than one week unless directed by a doctor
- on individuals who are allergic or sensitive to iodine
- or apply over large areas of the body
Stop use and ask a doctor
- if irritation and redness develop
- if condition persists for more than 72 hours
- in case of deep or puncture wounds, animal bites or serious burns.
- Other Information
- Inactive ingredients
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
APOTHECARY PVP TOPICAL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0939 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) NONOXYNOL-9 (UNII: 48Q180SH9T) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0939-08 236 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/13/2011 Labeler - Walgreen Company (008965063)