RELEEVIA MC- menthol and capsaicin patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)

Available from:

Patchwerx Labs, Inc

INN (International Name):

MENTHOL

Composition:

MENTHOL 5 g in 100 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Releevia MC Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness. Releevia MC Patch is an external analgesic/counterirritant. Releevia MC Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Releevia MC Patch is supplied in cartons with either 1 re-sealable pouch containing 5 patches or 3 re-sealable pouches each containing 5 patches each. NDC 69329-030-05 5 Patches per carton NDC 69329-030-15 15 Patches per carton Storage: Store below 25°C. Avoid direct sunlight. Manufactured for Patchwerx Labs, Inc. Las Vegas, NV 89118 800-590-8070

Authorization status:

unapproved drug other

Summary of Product characteristics

RELEEVIA MC- MENTHOL AND CAPSAICIN PATCH
PATCHWERX LABS, INC
_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._
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RELEEVIA MC PATCH
DESCRIPTION
Releevia MC Patch contains capsaicin and menthol in a localized dermal
delivery system. The capsaicin
in Releevia MC is a synthetic equivalent of the naturally occurring
compound found in chili peppers.
Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very
slightly soluble in water. The
menthol is slightly soluble in water.
Releevia MC is a single-use patch stored in a foil pouch. Each
Releevia MC patch is 8.3 cm x 12.5 cm
(104 cm
) and consists of a polyester backing film coated with a
drug-containing silicone adhesive
mixture, and covered with a removable polyester release liner.
The empirical formula for capsaicin is C
H
NO
, with a molecular weight of 305.42. The
chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is
an activating ligand for
transient receptor potential vanilloid 1 receptor (TRPV1) and it has
the following structure:
The empirical formula for menthol is C
H
O, with a molecular weight of 156.27. The chemical
compound menthol [(1 _R_,2 _S_,5 _R_)-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 Releevia MC Patch contains 0.0375% capsaicin (0.0375 grams of
capsaicin per patch) and 5.00%
menthol (5 grams of menthol per patch). The Releevia MC patch contains
the following inactive
ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl
Urea, EDTA Disodiumm Salt,
Glycerin, Iodoproynyl Butylcabamate, Methylparaben, Polysorbate 80,
Propylparaben, Sodium
Polyacrylate, and Water.
INDICATIONS AND USAGE
Releevia MC Patch is indicated for the temporary relief of minor aches
and muscle pains associated
with arthritis, simple backache, strains, muscle sorene