NDC Code(s) : 60760-687-30
Packager : St Marys Medical Park Pharmacy

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lidoderm 5 LIDOCAINE LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60760-687(NDC:63481-687)
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987)
LIDOCAINE700 mg in 1000 mg
Inactive Ingredients
Ingredient Name Strength
DIHYDROXYALUMINUM AMINOACETATE(UNII: DO250MG0W6)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
KAOLIN(UNII: 24H4NWX5CO)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYVINYL ALCOHOL(UNII: 532B59J990)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
TARTARIC ACID(UNII: W4888I119H)
UREA(UNII: 8W8T17847W)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60760-687-3021000 mg in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020612 12/21/2010

PRINCIPAL DISPLAY PANEL

Cut along dotted line

NDC 63481-687-01

ENDO PHARMACEUTICALS

Lidoderm LIDOCAINA PATCH 5%

Rx only

Each adhesive patch contains:
Lidocaine . . . . . . . .  700 mg ( 50 mg per gram adhesive) in an aqueous base.
Methylparaben and propylparaben as preservatives.

DOSAGE: For dosage and full prescribing information, read accompanying product information.

1 PATCH (10 cm x 14 cm)

Store at 25°C (77°F) ; excursions permitted to 15°-30°C (59°-86°F).

WARNING: Keep used and unused patches out of the reach of children, pets and others.

Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA 19317
Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695, Japan

PRINCIPAL DISPLAY PANEL

DIRECTIONS FOR USE

Do not store patch outside the sealed envelope.

Cut the envelope along the dotted line. Patches may be cut into smaller sizes with scissors prior to removal of the release liner. Safely discard the remaining unused pieces of cut patches where children and pets cannot get to them.

Remove the transparent release liner (clear plastic backing) before applications of patch to the skin.
Apply immediately after removal from the protective envelope.

Apply up to three (3) LIDODERM patches at one time to cover the most painful area. Apply patches only once for up to 12 hours in a 24 hours period (12 hours on and 12 hours off). Remove patch if irritation occurs.

Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

5 63481 - 687 -017

90001/YD

LOT:

EXP:

PRINCIPAL DISPLAY PANEL

Lidodern

LIDOCAINE PATCH 5%

NDC 63481-687-01

ENDO PHARMACEUTICALS

Lidoderm LIDOCAINA PATCH 5%

Rx only

Each adhesive patch contains:
Lidocaine . . . . . . . .  700 mg ( 50 mg per gram adhesive) in an aqueous base.
Methylparaben and propylparaben as preservatives.

Usual Dosage: See package insert for complete prescribing information.

30 PATCHES
30 Envelopes
Containing 1 Patch Each

Store at 25°C (77°F) ; excursions permitted to 15°-30°C (59°-86°F).

WARNING: Keep used and unused patches out of the reach of children, pets and others.

Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA 19317
Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695, Japan

Lidodern
LIDOCAINE PATCH 5%

DIRECTIONS FOR USE

Do not store patch outside the sealed envelope.

Cut the envelope along the dotted line. Patches may be cut into smaller sizes with scissors prior to removal of the release liner. Safely discard the remaining unused pieces of cut patches where children and pets cannot get to them.

Remove the transparent release liner (clear plastic backing) before applications of patch to the skin.
Apply immediately after removal from the protective envelope.

Apply up to three (3) LIDODERM patches at one time to cover the most painful area. Apply patches only once for up to 12 hours in a 24 hours period (12 hours on and 12 hours off). Remove patch if irritation occurs.

Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

8777/YD

5 63481 - 687 -017

ENDO PHARMACEUTICALS

Lidoderm
LIDOCAINA PATCH 5%

PRINCIPAL DISPLAY PANEL

Lidoderm