Xpacaine

XPACAINE- lidocaine and menthol, unspecified form patch
Synergist Laboratories LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Xpacaine Lidocaine USP and Menthol P atch

S ynergist Laboratories, LLC
Disclaimer: This drug has not been found by the FDA to be safe and effective, and this labeling has not been approved by the FDA.

Xpacaine Patch

DESCRIPTION

Xpacaine Patch contains lidocaine and menthol in a localized dermal delivery system. The lidocaine USP in Xpacaine is slightly soluble in water. The menthol in Xpacaine is slightly soluble in water.

Xpacaine is a single-use patch stored in a foil pouch. Each Xpacaine patch is 7.6 cm x 12.7 cm (97 cm²) and consists of a polyester backing film coated with a drug-containing acrylic adhesive mixture, and covered with a removable silicone coated paper release liner.

The empirical formula for lidocaine USP is C1 4 H2 2 N2 O, with a molecular weight of 234.33. The chemical compound lidocaine USP [2-(diethylamino)-N-(2,6-dimethylphenyl)], with a octanol:water partition ratio of 43 at pH 7.4. It has the following structure:

chemical strucure

The empirical formula for menthol is C10 H20 O, with a molecular weight of 156.27. The chemical compound menthol [(1R,2S,5R)-2-isopropyl-5-methylcyclohexanol] is an activating ligand for transient receptor potential cation channel subfamily M member 8 (TRPM8). It has the following structure:

chemical structure

Each Xpacaine Patch contains 4% Lidocaine and 4% Menthol. The Xpacaine patch contains the following inactive ingredients:

Polyacrylate Adhesive
Polyethylene Patch

Xpacaine Indications and Usage

Xpacaine Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backaches, strains, muscle soreness and stiffness. Xpacaine Patch is an external analgesic/counterirritant.

CONTRAINDICATIONS

Xpacaine Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS

For external use only.

Use only as directed.

Avoid contact with eyes and mucous membranes.

Do not cover with bandage.

Do not use on wounds or damaged skin.

Consult physician for children under 12.

Do not use if you are allergic to any known ingredients within this product

Stop use and ask a doctor if conditions worsen, symptoms persist for more than seven days, you develop a rash, or itching / excessive skin irritation occurs.

KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND ADMINISTRATION

Xpacaine patch contains 4% lidocaine USP and 4% menthol.

Instructions for Use
Clean and dry affected area
Tear open pouch. Unseal bag and remove patch
Remove release liner and apply directly to area of pain
Apply to affected area not more than 2 times daily
Wash hands with soap after applying patch
Reseal pouch containing unused patches

D IRECTIONS

Adults and children 12 years and over apply to affected area
Apply patch to affected area for up to 8 hours, clean area and wait 4 hours to reapply if needed

Children under 12 years consult physician before use

HOW SUPPLIED

Xpacaine Patch is supplied in cartons with 5 re-sealable pouches containing 3 patches each.
NDC 70131-010-15 15 Patches per carton

Storage: Store below 25°C. Avoid direct sunlight.

Manufactured for and Distributed by:

SYNERGIST LABS LLC
14205 SE 36th St
Suite 100
Bellevue, WA 98006
(425) 559-5202
Made in USA

PRINCIPAL DISPLAY PANEL

NDC 70131-010-15
Xpacaine
15 patches Rx Only

NDC 70131-010-15
Xpacaine
15 patches 
Rx Only
(click image for full-size original)
XPACAINE lidocaine and menthol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70131-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 40 mg
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 40 mg
Inactive Ingredients
Ingredient Name Strength
HIGH DENSITY POLYETHYLENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70131-010-15 5 POUCH in 1 CARTON contains a POUCH
1 3 PATCH in 1 POUCH This package is contained within the CARTON (70131-010-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/15/2015
Labeler — Synergist Laboratories LLC (079988043)

Revised: 12/2015 Synergist Laboratories LLC

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