PAINGO KFT- prilocaine, lidocaine, methyl salicylate, menthol kit

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R)

Dostępny od:

International Brand Management, LLC

INN (International Nazwa):

LIDOCAINE

Skład:

LIDOCAINE 25 mg in 1 g

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Lidocaine/Prilocaine Topical Cream (2.5%/2.5% -3x30gm) AMPlify Relief MM (Menthol 10.00%/Methyl Salicylate 30.00%)

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

PAINGO KFT- PRILOCAINE, LIDOCAINE, METHYL SALICYLATE, MENTHOL
INTERNATIONAL BRAND MANAGEMENT, LLC
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LIDOCAINE/PRILOCAINE TOPICAL CREAM
(2.5%/2.5% -3X30GM)
AMPLIFY RELIEF MM
(MENTHOL 10.00%/METHYL SALICYLATE 30.00%)
SEE ENCLOSED INSERT FOR FULL PRESCRIBING INFORMATION.
Keep away from heat and flame. Store at 20 to 25C (68 to 77) [See USP
Controlled Room Temperature].
KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.
INSTRUCTIONS FOR APPLICATION:
To measure 1 gram of lidocaine 2.5% and prilocaine 2.5%
cream, the cream should be gently squeezed out of the tube
as a narrow strip that is 1.45 inches (3.7 cm) 0.26
inches (6.6mm) wide. The strip of lidocaine 2.5% and
prilocaine 2.5% cream should be contained within the lines
of the diagram shown below.
FOR QUESTIONS OR
COMMENTS:
800-992-1190
PAINGO KFT- LIDOCAINE 2.5% AND PRILOCAINE 2.5%
19&Pacific Dover, DE 19904
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PAINGO KFT(LIDOCAINE 2.5% AND PRILOCAINE 2.5% CREAM, USP)
DESCRIPTION
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP is an emulsion in which
the oil phase is a eutectic
mixture of lidocaine and prilocaine cream in a ratio of 1:1 by weight.
This eutectic mixture has a
melting point below room temperature and therefore both local
anesthetics exist as a liquid oil rather
than as crystals. It is packaged in 5 gram and 30 gram tubes.
Lidocaine is chemically designated as acetamide,
2-(diethylamino)-N-(2,6-dimethylphenyl), has an
octanol: water partition ratio of 43 at pH 7.4, and has the following
structure:
Prilocaine is chemically designated as propanamide,
N-(2-methylphenyl)-2-(propylamino), has an
octanol: water partition ratio of 25 at pH 7.4, and has the following
structure:
Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg,
prilocaine 25 mg,
polyoxyethylene fatty acid esters (as emulsifiers),
carboxypolymethylene (as a thickening agent),
sodium hydroxide to adjust to a pH approximating 9, and purified water
to 1 gram. Lidocaine and
prilocaine cream contains no preservative, however it passes the USP
antimicrobial ef