GEN 7T (Page 2 of 2)

DRUG INTERACTIONS:

Antiarrhythmic Drugs: Gen7T Patch ® should be used with caution in patients receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.

Local Anesthetics: When Gen7T Patch ® is used concurrently with other products containing local anesthetic agents the amount absorbed from all formulations must be considered.

CARC INOGENESIS , MUTAGENESIS , IMPAIRMENT OF FERTILITY :

A minor metabolite, 2,6-xylidine, has been found to be carcinogenic in rats. The blood concentration of this metabolite is negligible following application of topical lidocaine. The effect of Gen7T Patch ® on fertility has not been studied.

PREGNANCY:

The safety of Gen7T Patch ® has not been established during pregnancy. There are no well-controlled studies in pregnant women. Gen7T Patch ® should not be used during pregnancy unless absolutely needed and discussed with a physician.

NURSING MOTHERS:

The effect of Gen7T Patch ® on the nursing infant has not been evaluated. Caution should be exercised when Gen7T Patch ® is administered to a nursing mother.

PEDIATRIC / GERIATRIC USE:

Safety and effectiveness in pediatric and geriatric patients have not been established.

ADVERSE REACTIONS:

The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time.

Serious adverse experiences following the administration of Gen7T Patch ® are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

OVERDOSAGE :

There have been no reports of over-dosage with Gen7T Patch ®. Signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.

PRINCIPAL DISPLAY PANEL

Lidocaine 3.5% Patch
Rx Only
Contains: 15 PATCHES

PRINCIPAL DISPLAY PANEL
GEN 7T Patch
Lidocaine 3.5% Patch
Rx Only
Contains:
15 PATCHES
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Lidocaine 3.5% Patch
Dispense by Prescription
Contains: 10 PATCHES

PRINCIPAL DISPLAY PANEL
GEN 7T Patch
Lidocaine 3.5% Patch
Dispense by Prescription
Contains:
10 PATCHES
(click image for full-size original)
GEN 7T lidocaine patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71073-206
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 490 mg
Inactive Ingredients
Ingredient Name Strength
POLYVINYL ALCOHOL, UNSPECIFIED
SORBITOL
GLYCERIN
CARBOXYMETHYLCELLULOSE SODIUM
SILICON DIOXIDE
TITANIUM DIOXIDE
PROPYLENE GLYCOL
TARTARIC ACID
MAGNESIUM HYDROXIDE
WATER
POLYACRYLIC ACID (8000 MW)
SODIUM POLYACRYLATE (8000 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71073-206-10 10 PATCH in 1 BOX None
2 NDC:71073-206-35 15 PATCH in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/29/2020
Labeler — Beijing HKKY Medical Tech. Co., Ltd. (544434817)
Establishment
Name Address ID/FEI Operations
Beijing HKKY Medical Tech. Co., Ltd. 544434817 manufacture (71073-206)

Revised: 07/2020 Beijing HKKY Medical Tech. Co., Ltd.

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