Elemar Patch (Page 3 of 3)

OVERDOSAGE

Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS, Systemic Reactions), drug blood concentration should be checked. The management of overdose includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdose with lidocaine.

In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics.

The oral LD₅₀ of lidocaine HCl is 459 (346 to 773) mg/kg (as the salt) in non-fasted female rats and 214 (159 to 324) mg/kg (as the salt) in fasted female rats, which are equivalent to roughly 4000 mg and 2000 mg, respectively, in a 60 to 70 kg man based on the equivalent surface area dosage conversion factors between species.

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 20^o to 25^o C (68^o to 77^o 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)

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

PRINCIPAL DISPLAY PANEL

The packaging for Elemar Patch is shown below.

ELEMAR PATCH lidocaine kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72835-502

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72835-502-02 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 unapproved drug other 02/22/2022

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	label (72835-502)

Revised: 02/2023 V2 Pharma, LLC