Label: POVIDONE-IODINE SCRUB SWABSTICK- povidone-iodine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 50730-4401-1 - Packager: H and P Industries, Inc. dba Triad Group
- 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.
Drug Label Information
Updated November 24, 2009
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- ACTIVE INGREDIENT
- PURPOSE
- USES
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WARNINGS
For external use only.
Do not
- use in the eyes
- apply over large areas of the body
- use on individuals who are allergic or sensitive to iodine
- use as a first aid antiseptic for longer than 1 week unless directed by a doctor
- DIRECTIONS
- SPL UNCLASSIFIED SECTION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
- LABEL INFORMATION
- CARTON INFORMATION
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INGREDIENTS AND APPEARANCE
POVIDONE-IODINE SCRUB SWABSTICK
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50730-4401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine .075 mg in 1 mL Inactive Ingredients Ingredient Name Strength citric acid monohydrate (UNII: 2968PHW8QP) glycerin (UNII: PDC6A3C0OX) nonoxynol-9 (UNII: 48Q180SH9T) polyethylene glycol 300 (UNII: 5655G9Y8AQ) sodium hydroxide (UNII: 55X04QC32I) sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50730-4401-1 50 in 1 BOX 1 1 in 1 POUCH 1 1.7 mL in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 01/14/1987 Labeler - H and P Industries, Inc. dba Triad Group (050259597) Registrant - H and P Industries, Inc. dba Triad Group (050259597) Establishment Name Address ID/FEI Business Operations H and P Industries, Inc. dba Triad Group 050259597 manufacture