Label: TRIADINE SCRUB- 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 April 19, 2010
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- ACTIVE INGREDIENT
For external use only.
Do not use
- in the eyes
- on individuals who are allergic or sensitive to iodine
- as a first aid antiseptic for longer than 1 week unless directed by a doctor
As a surgical hand scrub for use by health care professionals
- clean under nails with a nail pick
- nails should be maintained with 1 millimeter free edge
- wet hands and forearms
- apply milliliter (teaspoon) or palmful to hands and forearms
- scrub thoroughly paying particular attention to nails, cuticles and interdigital spaces
- rinse and repeat scrub
- clean the affected area
- apply to the operative site prior to surgery
- clean the affected area
- apply a small amount of this product to the area 1-3 times daily
- may be covered with a sterile bandage
- if bandaged, let dry first
- SPL UNCLASSIFIED SECTION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
Cat. No. 10-8304
7.5% Topical Solution
ANTISEPTIC / GERMICIDE
- PRE-SURGICAL HAND SCRUB. Significantly reduces the number of micro-organisms on hand and forearms prior to surgery or patient care.
- 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 EXTERNAL USE ONLY!
4 Fluid Ounces (118 ml)
TRIAD GROUP, INC.
700 West North Shore Drive
Hartland, WI 53029
MADE IN USA
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50730-8304 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 mL 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:50730-8304-2 118 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