Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 5

of 3

0 C

hlor

hexi

dine

Glu

cona

te 2

% S

olut

ion

S

ecti

on 1

.14.

1-D

raft

Lab

elin

g

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 1:

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

4-o

un

ce D

yna-

Hex

2%

CH

G

Lab

el B

ase

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 6

of 3

0 C

hlor

hexi

dine

Glu

cona

te 2

% S

olut

ion

S

ecti

on 1

.14.

1-D

raft

Lab

elin

g

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 1

(con

t’d):

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

4-o

un

ce D

yna-

Hex

2%

CH

G

Fro

nt

Pan

el (

Boo

kle

t F

ron

t)

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 7

of 3

0 C

hlor

hexi

dine

Glu

cona

te 2

% S

olut

ion

S

ecti

on 1

.14.

1-D

raft

Lab

elin

g

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent #

1 (c

ont’d

): N

DA

19-

422

-Rev

ised

lab

elin

g, 4

-ou

nce

Dyn

a-H

ex 2

% C

HG

P

age

2 (B

ack

of

Cov

er)

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 8

of 3

0 C

hlor

hexi

dine

Glu

cona

te 2

% S

olut

ion

S

ecti

on 1

.14.

1-D

raft

Lab

elin

g

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 1

(con

t’d):

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

4-o

un

ce D

yna-

Hex

2%

CH

G

Pag

e 3

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n S

ecti

on 1

.14.

1-D

raft

Lab

elin

g

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

Att

ach

men

t #

1 (c

ont’d

): N

DA

19-

422

-Rev

ised

lab

elin

g, 4

-ou

nce

Dyn

a-H

ex 2

% C

HG

P

age

4

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 9

of 3

0 C

hlor

hexi

dine

Glu

cona

te 2

% S

olut

ion

S

ecti

on 1

.14.

1-D

raft

Lab

elin

g

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 2:

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

8-o

un

ce D

yna-

Hex

2%

CH

G

Lab

el B

ase

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 10

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 2

(con

t’d):

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

8-o

un

ce D

yna-

Hex

2%

CH

G

PD

P

Reference ID: 3229728

Xttrium Laboratories, Inc. Confidential Page 11 of 30 Chlorhexidine Gluconate 2% Solution Section 1.14.1-Draft Labeling

Amendment to NDA 19-422/S-0047-Revision Request

Attachment # 2 (cont’d): NDA 19-422 -Revised labeling, 8-ounce Dyna-Hex 2% CHG

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 12

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 2

(con

t’d):

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

8-o

un

ce D

yna-

Hex

2%

CH

G

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 13

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 3:

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

16-

oun

ce D

yna-

Hex

2%

CH

G

PD

P

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 14

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 3

(con

t’d):

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

16-

oun

ce D

yna-

Hex

2%

CH

G

Pan

el 2

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 15

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 3

(con

t’d):

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

16-

oun

ce D

yna-

Hex

2%

CH

G

Pan

el 3

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 16

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 3

(con

t’d):

ND

A 1

9-42

2-R

evis

ed la

bel

ing,

16-

oun

ce D

yna-

Hex

2%

CH

G

Pan

el 4

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 17

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 3

(con

t’d):

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

16-

oun

ce D

yna-

Hex

2%

CH

G

Pan

el 5

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 18

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 4:

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

30-

oun

ce D

yna-

Hex

2%

CH

G

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 19

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 4

(con

t’d):

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

30-

oun

ce D

yna-

Hex

2%

CH

G

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 20

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 5:

ND

A 1

9-42

2-R

evis

ed la

bel

ing,

32-

oun

ce D

yna-

Hex

2%

CH

G

Fro

nt

Pan

el

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 21

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 5

(con

t’d):

ND

A 1

9-42

2-R

evis

ed la

bel

ing,

32-

oun

ce D

yna-

Hex

2%

CH

G

Pan

el 2

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 22

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 6:

ND

A 1

9-42

2-R

evis

ed la

bel

ing,

1-G

allo

n D

yna-

Hex

2%

CH

G

PD

P

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 23

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 6

(con

t’d):

ND

A 1

9-42

2-R

evis

ed la

bel

ing,

1-G

allo

n D

yna-

Hex

2%

CH

G

Pan

el 1

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 24

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 6

(con

t’d):

ND

A 1

9-42

2 -R

evis

ed la

bel

ing,

1-G

allo

n D

yna-

Hex

2%

CH

G

Pan

el 2

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 25

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 7:

ND

A 1

9-42

2-R

evis

ed la

bel

ing,

Bac

tosh

ield

1-L

2%

CH

G

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 26

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 7

(con

t’d):

ND

A 1

9-42

2-R

evis

ed la

bel

ing,

Bac

tosh

ield

1-L

2%

CH

G

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 27

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 7

(con

t’d):

ND

A 1

9-42

2-R

evis

ed la

bel

ing,

Bac

tosh

ield

1-L

2%

CH

G

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 28

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttach

men

t # 7

(con

t’d):

ND

A 1

9-42

2-R

evis

ed la

bel

ing,

Bac

tosh

ield

1-L

2%

CH

G

Reference ID: 3229728

Xtt

rium

Lab

orat

orie

s, I

nc.

Con

fid

enti

al

Pag

e 29

of

30

Chl

orhe

xidi

ne G

luco

nate

2%

Sol

utio

n

Sec

tion

1.1

4.1-

Dra

ft L

abel

ing

Am

endm

ent t

o N

DA

19-

422/

S-0

047-

Rev

isio

n R

eque

st

A

ttac

hm

ent

# 8:

ND

A 1

9-42

2-R

evis

ed L

abel

ing,

BD

EZ

-Scr

ub

32-

oz 2

% C

HG

Reference ID: 3229728

Xttrium Laboratories, Inc. Confidential Page 30 of 30 Chlorhexidine Gluconate 2% Solution Section 1.14.1-Draft Labeling

Amendment to NDA 19-422/S-0047-Revision Request

Attachment # 9: NDA 19-422-Revised Labeling, GOJO Provon 1.2 L 2% CHG

Reference ID: 3229728

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

JOEL SCHIFFENBAUER12/12/2012

Reference ID: 3229728