LIDOCAINE HYDROCHLORIDE- lidocaine gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

Gensco Laboratories, LLC

INN (International Name):

LIDOCAINE

Composition:

LIDOCAINE 40 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Stage I - IV pressure ulcers - Venous stasis ulcers - Ulcerations caused by mixed vascular etiologies - Diabetic skin ulcers - First and second degree burns - Post-surgical incisions, cuts and abrasions. LDO Plus contains Lidocaine Hydrochloride USP and is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of LDO Plus. Do not use LDO Plus on traumatized mucosa or in the presence of secondary bacterial infection of the area of proposed application.

Product summary:

LDO Plus (Lidocaine HCl USP 4%) 1/2 oz (15g) 15mL Airless Pump - NDC 35781-0500-1 1.00 oz (30g) 30mL Airless Pump - NDC 35781-0500-3 3.00 oz (90g) 90mL Airless Pump - NDC 35781-0500-9 Gensco Labratories, LLC 8550 NW 33rd St Suite 200 Doral, FL 33122

Authorization status:

Premarket Notification

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- DRESSING, WOUND AND BURN, HYDROGEL W/DRUG
AND/OR
BIOLOGIC GEL
GENSCO LABORATORIES, LLC
----------
LDO PLUS (LIDOCAINE HCL USP) 4%
RX ONLY
DO NOT USE IN THE EYES.
DESCRIPTION
A soothing hydrogel wound dressing that promotes a moist wound
environment that is ideal for the
healing process
LDO Plus contains Lidocaine HCl USP 4%, which is chemically designated
as acetamide, 2-
(diethylamino)-_N_-(2,6-dimethylphenyl)-, and has the following
structural formula:
INDICATIONS AND USAGE
Stage I - IV pressure ulcers
Venous stasis ulcers
Ulcerations caused by mixed vascular etiologies
Diabetic skin ulcers
First and second degree burns
Post-surgical incisions, cuts and abrasions.
CONTRAINDICATIONS
LDO Plus contains Lidocaine Hydrochloride USP and is contraindicated
in patients with a known
history of hypersensitivity to local anesthetics of the amide type or
to other components of LDO Plus.
Do not use LDO Plus on traumatized mucosa or in the presence of
secondary bacterial infection of the
area of proposed application.
WARNINGS
Do not use this product if you are allergic to any ingredients. If
condition worsens or does not improve
within 7 days, consult a physician. Do not use on children under 2
years of age without consulting a
physician.
Avoid contact with eyes. Do not use in large quantities.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
KEEP OUT OF REACH OF CHILDREN.
PRECAUTIONS
IF IRRITATION OR SENSITIVITY OCCURS OR INFECTION APPEARS, DISCONTINUE
USE AND INSTITUTE APPROPRIATE
THERAPY. LDO PLUS HYDROGEL SHOULD BE USED WITH CAUTION IN ILL,
ELDERLY, DEBILITATED PATIENTS AND
CHILDREN WHO MAY BE MORE SENSITIVE TO THE SYSTEMIC EFFECTS OF
LIDOCAINE HYDROCHLORIDE USP. IN
CASE OF ACCIDENTAL INGESTION GET MEDICAL HELP OR CONTACT POISON
CONTROL CENTER RIGHT AWAY.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY
Studies of lidocaine in animals to evaluate the carcinogenic potential
of the effect on fertility have not
been conducted.
USE IN PREGNANCY
Teratogenic Effects:
Teratogenic Effects. Pregnanc