LMR Plus (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Apply lidocaine patch 5% to intact skin to cover the most painful area. Apply the prescribed number of patches (maximum of 3), only once for up to 12 hours within a 24-hour period. Patches may be cut into smaller sizes with scissors prior to removal of the release liner. (See HANDLING AND DISPOSAL) Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination.

If irritation or a burning sensation occurs during application, remove the patch(es) and do not reapply until the irritation subsides.

When lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Lidocaine patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming or showering.

HANDLING AND DISPOSAL

Hands should be washed after the handling of lidocaine patch 5%, and eye contact with lidocaine patch 5% should be avoided. Do not store patch outside the sealed envelope. Apply immediately after removal from the protective envelope. 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. Lidocaine patch 5% should be kept out of the reach of children.

HOW SUPPLIED

Lidocaine patch 5% is available as the following:

Carton of 30 patches, packaged into individual child-resistant envelopes.

NDC 0591-3525-30

Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature].

For more information, call Actavis at 1-800-272-5525.

Manufactured by:
Actavis Laboratories UT, Inc.
Salt Lake City, UT 84108 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: February 2015

LIDOCAINE DISPLAY PANEL

NDC 0591-3525-30
Lidocaine
Patch 5%

Each adhesive patch contains:
Lidocaine, 700 mg (50 mg per gram adhesive) in an aqueous base.
Inactive components: non-woven polyethylene terephthalate (PET) backing, glycerin, D-sorbitol,
propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium,
gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben
(preservative), propylparaben (preservative), edetate disodium, and a PET release liner.
Usual dosage: For dosage and full prescribing information, read accompanying product information.
Store at 20° to 25°C [See USP Controlled Room Temperature].
WARNING: Keep used and unused patches out of the reach of children, pets and others.
Rx only
30 Patches(30 Envelopes Containing 1 Patch Each)

Lidocaine
(click image for full-size original)

Menthol

Active Ingredients

Menthol USP 6%

Purpose

Purpose

External Analgesic

Keep out of reach of children

Keep out of reach of children

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Directions

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus limon (lemon) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol

Questions or Comments

1-800-225-3963

Menthol inner packaging

Menthol inner packaging
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

The packaging for LMR Plus is shown below.

LRM Plus Packaging
(click image for full-size original)
LMR PLUS lidocaine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72835-501
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72835-501-02 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 30 POUCH 30 g
Part 2 1 BOTTLE, PLASTIC 85 g
Part 1 of 2
LIDOCAINE lidocaine patch
Product Information
Item Code (Source) NDC:0591-3525
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
SORBITOL
PROPYLENE GLYCOL
POLYVINYL ALCOHOL, UNSPECIFIED
UREA
CARBOXYMETHYLCELLULOSE SODIUM
GELATIN, UNSPECIFIED
KAOLIN
TARTARIC ACID
DIHYDROXYALUMINUM AMINOACETATE
METHYLPARABEN
PROPYLPARABEN
EDETATE DISODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3525-30 30 POUCH in 1 CARTON contains a POUCH
1 1 g in 1 POUCH This package is contained within the CARTON (0591-3525-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200675
Part 2 of 2
SORE NO MORE COOL THERAPY menthol gel
Product Information
Item Code (Source) NDC:61577-3235
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 0.06 g in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CARBOMER HOMOPOLYMER TYPE C
DECYL GLUCOSIDE
WATER
GRAPEFRUIT SEED OIL
GREEN TEA LEAF
FILIPENDULA ULMARIA FLOWER
ROSA CENTIFOLIA FLOWER OIL
SODIUM CARBONATE
GLYCERIN
WITCH HAZEL
YUCCA SCHIDIGERA ROOT
ORANGE PEEL
LEMON OIL
PHENOXYETHANOL
CAPRYLYL GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61577-3235-5 85 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200675 06/03/2019
Labeler — V2 Pharma, LLC (102457346)
Establishment
Name Address ID/FEI Operations
Actavis Pharma, Inc. 079589880 manufacture (0591-3525)
Establishment
Name Address ID/FEI Operations
SOMBRA COSMETICS INC. 097464309 manufacture (61577-3235), label (61577-3235)
Establishment
Name Address ID/FEI Operations
V2 Pharma, LLC 102457346 relabel (72835-501)

Revised: 01/2022 V2 Pharma, LLC

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