Leep RediKit (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

Lugol’s (STRONG IODINE SOLUTIONS USP) NDC 59365-6064-0

PRINCIPAL DISPLAY PANEL
8mL       NDC 59365-6064-0
Lugol’s 
(STRONG IODINE SOLUTIONS USP)
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

AstrinGYN ® (ferr ic subsulfate ) NDC 59365-6065- 0

PRINCIPAL DISPLAY PANEL
8gm       NDC 59365-6065-0
AstrinGyn ®
(Ferric Subsulfate)
Aqueous
(click image for full-size original)
LEEP REDIKIT mepivacaine hydrochloride, lidocaine hydrochloride, epinephrine bitartrate, iodine, potassium iodide, ferric subsulfate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59365-6061
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59365-6061-1 1 KIT in 1 PACKAGE None
2 NDC:59365-6061-2 5 PACKAGE in 1 PACKAGE contains a PACKAGE (59365-6061-1)
2 NDC:59365-6061-1 1 KIT in 1 PACKAGE This package is contained within the PACKAGE (59365-6061-2)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, MULTI-DOSE 10 mL
Part 2 1 VIAL, SINGLE-USE 8 mL
Part 3 1 VIAL, SINGLE-USE 8 g
Part 1 of 3
XYLOCAINE lidocaine hydrochloride anhydrous and epinephrine bitartrate injection, solution
Product Information
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
EPINEPHRINE BITARTRATE (EPINEPHRINE) EPINEPHRINE 0.01 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE 0.2 mg in 1 mL
SODIUM CHLORIDE 7 mg in 1 mL
SODIUM METABISULFITE 0.5 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA006488
Part 2 of 3
LUGOLS STRONG IODINE iodine and potassium iodide solution
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IODINE (IODINE) IODINE 0.05 g in 1 mL
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 0.100 g in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 8 mL in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER
Part 3 of 3
ASTRINGYN ferric subsulfate solution
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERRIC SUBSULFATE (FERRIC CATION) FERRIC CATION 259 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
POVIDONE
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 8 g in 1 VIAL, SINGLE-USE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/31/2015
Labeler — CooperSurgical, Inc. (801895244)

Revised: 08/2016 CooperSurgical, Inc.

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