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 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:
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:
Each Xpacaine Patch contains 4% Lidocaine and 4% Menthol. The Xpacaine patch contains the following inactive ingredients:
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.
Xpacaine Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.
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.
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
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
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
Bellevue, WA 98006
Made in USA
15 patches Rx Only
|XPACAINE lidocaine and menthol patch|
|Labeler — Synergist Laboratories LLC (079988043)|
Revised: 12/2015 Synergist Laboratories LLC
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