Label: TRIADINE PREP- povidone-iodine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 50730-8204-3 - Packager: 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 April 19, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DIRECTIONS
- SPL UNCLASSIFIED SECTION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS
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LABEL INFORMATION
Cat. No. 10-8204
NDC 50730-8204-4
TRIADINE™POVIDONE-IODINE, USP
PREP SOLUTION
10% Topical Solution
ANTISEPTIC / GERMICIDE
- ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
- FIRST AID ANTISEPTIC to help prevent the risk of infection in minor cuts, scrapes and burns.
- For Hospital and Professional Use.
For External Use Only!
4 Fluid Ounces (118 ml)www.triad-group.net
TRIAD GROUP, INC.
700 West North Shore Drive
Hartland, WI 53029 MADE IN USA
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INGREDIENTS AND APPEARANCE
TRIADINE PREP
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50730-8204 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M) povidone-iodine .10 mg in 1 mL Inactive Ingredients Ingredient Name Strength citric acid monohydrate (UNII: 2968PHW8QP) glycerin (UNII: PDC6A3C0OX) sodium hydroxide (UNII: 55X04QC32I) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50730-8204-3 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 06/21/1985 Labeler - Triad Group (050259597) Establishment Name Address ID/FEI Business Operations Triad Group 050259597 manufacture