BETADINE- pov done- od ne solut on

Rebel D str butors Corp

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Betad ne® 5%
Ster le Ophthalm c
Prep Solut on
(pov done- od ne ophthalm c solut on)
(0.5% ava lable od ne)

DESCRIPTION
Pov done-Iod ne s a broad-spectrum m crob c de w th the chem cal formulas:
2-pyrrol d none, 1- ethenyl-, homopolymer, compound w th od ne; 1-v nyl-2-pyrrol d none polymer, compound w th od ne. The structural formula s as follows:

BETADINE® 5% Ster le Ophthalm c Prep Solut on conta ns 5% pov done- od ne (0.5% ava lable od ne) as a ster le dark brown solut on stab l zed by glycer n. Inact ve Ingred ents: c tr c ac d,
glycer n, nonoxynol-9, sod um chlor de, sod um hydrox de, and d bas c sod um phosphate.

CLINICAL PHARMACOLOGY
A placebo-controlled study n 38 normal volunteers y elded data for 36 subjects who showed a mean log10 reduct on of 3.05 log10 un ts n total aerobes at 10 m nutes follow ng prepp ng the sk n w th
BETADINE® 5% Ster le Ophthalm c Prep Solut on compared w th reduct on of 1.58 log10 un ts after prepp ng w th veh cle free of the od ne complex. Th s placebo-controlled study nd cates a mean
log10 reduct on by the od ne complex compared w th the control solut on of 1.47 log10 un ts at 10 m nutes and 1.79 log10 un ts at 45 m nutes. The base-l ne mean aerob c bacter al count was 7,586
organ sms per square cm.

INDICATIONS AND USAGE

BETADINE® 5% Ster le Ophthalm c Prep Solut on for the eye s nd cated for prepp ng of the per ocular reg on (l ds, brow, and cheek) and rr gat on of the ocular surface (cornea, conjunct va, and
palpebral forn ces).

CONTRAINDICATIONS
Do not use on nd v duals known to be sens t ve to od ne, or other components of th s product.

WARNINGS
FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.

PRECAUTIONS:

General
No stud es are ava lable n pat ents w th thyro d d sorders; therefore, caut on s adv sed n us ng BETADINE® 5% Ster le Ophthalm c Prep Solut on n these pat ents due to the poss b l ty of od ne
absorpt on.

Carc nogenes s, Mutagenes s, Impa rment of Fert l ty

No long term stud es n an mals have been performed to evaluate the carc nogen c or mutagen c potent al of pov done- od ne. One report of the mutagen c potent al of pov done- od ne nd cated that t
was pos t ve n a mod f cat on of the Ames S. typh mur um model, but these results could not be reproduced by another researcher. Another test us ng mouse lymphoma and Balb/3T3 cells showed
that pov done- od ne has no s gn f cant mutagen c or transformat on capab l t es. Other data nd cated that t does not produce mutagen c effects n m ce or hamsters accord ng to the dom nant lethal
test, m cronucleus test, and chromosome analys s.

Pregnancy
Category C: An mal reproduct on stud es have not been conducted w th BETADINE® 5% Ster le Ophthalm c Prep Solut on. It s also not known whether BETADINE® 5% Ster le Ophthalm c Prep
Solut on can cause fetal harm when adm n stered to a pregnant woman or can affect reproduct ve capac ty. BETADINE® 5% Ster le Ophthalm c Prep Solut on should only be used on a pregnant
woman f clearly needed.

Nurs ng Mothers
Because of the potent al for ser ous adverse react ons n nurs ng nfants from BETADINE® 5% Ster le Ophthalm c Prep Solut on, a dec s on should be made to d scont nue nurs ng or d scont nue the
drug, tak ng nto account the mportance of the drug to the mother.

Ped atr c Use

Safety and effect veness n ped atr c pat ents have not been establ shed.

Ger atr c Use

No overall d fferences n safety or effect veness have been observed between elderly and younger pat ents.

ADVERSE REACTIONS
Local sens t v ty has been exh b ted by some nd v duals to pov done- od ne ophthalm c solut on.

DOSAGE AND ADMINISTRATION

Wh le the nner surface and contents of the mmed ate conta ner ( .e. bottle) are ster le, the outer surface of the bottle s not ster le. The use of the bottle n a ster le f eld should be avo ded.
BETADINE® 5% Ster le Ophthalm c Prep Solut on s used as
follows:
1. Make sure conta ner s ntact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently squeeze ent re contents of bottle nto a ster le prep cup.
2. Saturate ster le cotton-t pped appl cator to prep lashes and l d marg ns us ng one or more appl cators per l d; repeat once.
3. Saturate ster le prep sponge or other su table mater al to prep l ds, brow and cheek n a c rcular ever-expand ng fash on unt l the ent re f eld s covered; repeat prep three (3) t mes.
4. Wh le separat ng the l ds, rr gate the cornea, conjunct va and palpebral forn ces w th BETADINE® 5% Ster le Ophthalm c Prep Solut on us ng a ster le bulb syr nge.
5. After the BETADINE® 5% Ster le Ophthalm c Prep Solut on has been left n contact for two m nutes, ster le sal ne solut on n a bulb syr nge should be used to flush the res dual prep solut on from
the cornea, conjunct va, and the palpebral forn ces.

HOW SUPPLIED
BETADINE® 5% Ster le Ophthalm c Prep Solut on s packaged under ster le cond t ons and suppl ed n 1 fl.oz. (30 mL) form sealed blue HDPE bottles (NDC #42254-006-30).
Store at 15-25°C (59-77°F).
Rx Only
S ngle use only

Manufactured for:
Alcon Laborator es, Inc.
Fort Worth, TX 76134

Manufactured by:
Catalent Pharma Solut ons, LLC
Woodstock, IL 60098
Relabeled by:
Rebel D str butors Corp
Thousand Oaks, CA 91320

BETADINE® s a reg stered trademark of The Purdue Freder ck Company.

9002984-1007

Pr nc pal D splay Panel

NDC 42254-006-30
Betad ne® 5%
Ster le Ophthalm c Prep Solut on
(pov done- od ne
ophthalm c solut on)
For Pre-Operat ve Prep and
Irr gat on of the Ocular and
Per ocular Surfaces
Flush eye thoroughly w th
ster le sal ne solut on after
each use.
Rx Only
1 Fl. Oz. (30 mL)

BETADINE
pov done- od ne solut on

Product Informat on
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-006(NDC:0065-0411)

Route of Adm n strat on OPHTHALMIC

Act ve Ingred ent/Act ve Mo ety

Ingred ent Name Bas s of Strength Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 5 mg n 1 mL

Inact ve Ingred ents

Ingred ent Name Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

Packag ng
# Item Code Package Descr pt on Market ng Start Date Market ng End Date
1 NDC:42254-006-30 30 mL n 1 BOTTLE

Market ng Informat on
Market ng Category Appl cat on Number or Monograph C tat on Market ng Start Date Market ng End Date
NDA NDA018634 04/01/2000

Labeler - Rebel D str butors Corp (118802834)

Establ shment
Name Address ID/FEI Bus ness Operat ons
Rebel D str butors Corp 118802834 RELABEL, REPACK

Rev sed: 10/2011 Rebel D str butors Corp