DX1 ORAGENOMIC MEDICATED DNA COLLECTION SCREEN- lidocaine hydrochloride kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)

Disponível em:

IT3 Medical LLC

DCI (Denominação Comum Internacional):

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Composição:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type, or to other components of the solution. Purpose First Aid Antiseptic Use First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns. Do not use - in the eyes or apply over large areas of the body. - longer than 1 week unless directed by a doctor. Consult a doctor in case of deep or puncture wounds, animal bites, or serious burns. Stop use and consult a doctor if the condition persists or gets worse. Purpose For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat. Indications and Usage - For temporary relief of minor soreness and/

Resumo do produto:

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is a clear, viscous liquid with a very slight orange flavor available in 100 mL polyethylene squeeze bottles and in 15 mL unit dose in trays of ten cups. The solution should be stored in a cool dry place at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Keep this and all medications out of the reach of children. SHAKE WELL BEFORE USE. Package not child-resistant Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Made in U.S.A. Rev. 775:07 03/15 Assembled and Distributed by IT3 Medical, LLC 4447 N Central Expy; Ste 110-106 Dallas, TX 75205 For questions or comments: [e-mail] www.IT3-Medical.com

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DX1 ORAGENOMIC MEDICATED DNA COLLECTION SCREEN- LIDOCAINE
HYDROCHLORIDE
IT3 MEDICAL LLC
----------
DX1 ORAGENOMIC MEDICATED DNA COLLECTION SCREEN
A Topical Anesthetic for the Mucous Membranes of the Mouth and
Pharynx.
RX ONLY
FOR ORAL USE ONLY
WARNING: LIFE-THREATENING AND FATAL EVENTS IN INFANTS AND YOUNG
CHILDREN
Postmarketing cases of seizures, cardiopulmonary arrest, and death in
patients
under the age of 3 years have been reported with use of Lidocaine
Hydrochloride
Oral Topical Solution, USP (Viscous) 2% when it was not administered
in strict
adherence to the dosing and administration recommendations. In the
setting of
teething pain, Lidocaine Hydrochloride Oral Topical Solution, USP
(Viscous) 2%
should generally not be used. For other conditions, the use of the
product in
patients less than 3 years of age should be limited to those
situations where safer
alternatives are not available or have been tried but failed.
To decrease the risk of serious adverse events with use of Lidocaine
Hydrochloride
Oral Topical Solution, USP (Viscous) 2%, instruct caregivers to
strictly adhere to the
prescribed dose and frequency of administration and store the
prescription bottle
safely out of reach of children.
DESCRIPTION
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%
contains a local
anesthetic agent and is administered topically. Lidocaine
Hydrochloride Oral Topical
Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is
chemically
designated as acetamide, 2-(diethylamino)-N- (2,6 dimethylphenyl)-,
monohydrochloride
and has the following structural formula:
The molecular formula of lidocaine is C
H
N O. The molecular weight is 234.34.
14
22
2
COMPOSITION OF SOLUTION
Each mL contains 20 mg of lidocaine HCl. In addition each mL contains
the following
inactive ingredients: Carboxymethylcellulose sodium, methylparaben,
natural orange
flavor, propylparaben, purified water, and saccharin sodium. The pH is
adjusted to 5.0 to
7.0 by means of hydrochloric acid and/or sodium hydroxide.
CLINICAL PHAR