GEN7T- lidocaine lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)
Available from:
7T Pharma LLC
Administration route:
TOPICAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Gen7T  Lotion ®  is contraindicated in patients with a known hypersensitivity to lidocaine, or any of the topical amide-like local anesthetic preparations or to any other component of the product.
Product summary:
Gen7T   Lotion ®  is supplied in the following dosage form: 120 grams Made in USA Rx Only Manufactured for: 7T Pharma, LLC 220 Emerald Vista Way Las Vegas, NV 89144 800.941.2848 NDC: 70645-627-35 Size: 120 grams
Authorization status:
unapproved drug other
Authorization number:
70645-627-35

GEN7T- lidocaine lotion

7T Pharma LLC

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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Gen7T Lotion

Gen7T Lotion

7T Pharma, LLC

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What is Gen7T Lotion

?

This is a topical lotion consisting of the local anesthetic, lidocaine.

What is Gen7T Lotion used for?

The lotion is applied topically for use on normal intact skin for temporary relief of pain and itching due

to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites. Read the information

sheet provided before you start using this medication and each time you get a refill. If you have any

questions, please consult your doctor or pharmacist. Inform your doctor if your condition does not

improve or if it worsens. The use of this medication shall be used under the supervision of a physician

only as it may be used in conjunction with other therapies.

This information may not include all of the information needed to use Gen7T Lotion safely and

effectively.

For Topical Use Only

What are the possible side effects with Gen7T Lotion

Common: itching, redness or flaking of the skin following application (note: the majority of patients

experience no significant adverse events following application).

NOTE: serious side effects are, in general, related to accidental toxicity of medication by applying

considerably more than directed by your doctor or pharmacist or by ingesting the contents of the

lotion or using this lotion in conjunction with other lidocaine containing products.

Tell your healthcare provider about all the medicines you take. This includes prescription and

nonprescription medicines, vitamins, and herbal supplements

Avoid excessive alcohol usage, since it may increase the potential for Central Nervous System

(CNS) effects such as dizziness, confusion, lightheadedness and orthostatic hypotension.

This is not a complete list of the possible side effects. For more information, talk with your doctor or

pharmacist. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

Adults and children 12 years and over:

Apply Gen7T Lotion

to intact skin of the affected area. Clean and dry the affected area and apply

product direct to the skin, up to 4 times daily. Clothing may be worn over the area of application. If

irritation or a burning sensation occurs during application, wash the lotion off the skin and do not

reapply until the irritation subsides.

Children under 12 years of age: Consult a doctor

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WARNINGS

1. Do not use:

On the face or rashes

On wounds, damaged or infected skin

On eyes, mouth, genitals, or other mucous membranes

With a bandage or heating pad

2. Consult physician for children under 12 years of age

3. Stop and consult your prescriber

If pain worsens

If you are allergic to any of the ingredients in this product

If excessive skin irritation develops

If using concurrently with any other external pain-relieving products

If you are pregnant, planning to become pregnant, or breastfeeding

If symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

Call your healthcare provider right away if you get any of the following warning signs or any

other unusual symptoms that concern you:

Shortness of breath

Swelling or numbness of the tongue or throat

Severe headache or vomiting

Dizziness or faintness

Changes in vision or speech

Excessive dosage, or short interval between doses, can result in high plasma levels and serious adverse

effects. Patients should be instructed to strictly adhere to the recommended dosage and administration

guidelines set forth in this literature and on your prescription label. The management of serious adverse

reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs.

General information about the safe and effective use Gen7T Lotion

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet.

Do not use this product for another indication unless instructed and prescribed by a physician. Do not

give this drug to anyone else, even if they have the same condition. This product is intended for use as

prescribed by a physician.

How should I store Gen7T Lotion

Store product at room temperature at 68°F to 77°F (20°C to 25°C). Keep away from heat or sunlight.

Protect from excessive moisture. Safely discard product after expiration date posted on the product

label. Discard this product away from small children or animals.

DO NOT use the product after the expiration date printed on the bottle.

What are the active ingredients in Gen7T Lotion

?

The lotion consists of 3.5% lidocaine.

INACTIVE INGREDIENTS:

Phenoxyethanol, Ethylhexylglycerin, Water, Glycerin, Disodium EDTA, Acrylates/C10-30 Alkyl

Acrylate Crosspolymer, Caprylic/Capric Triglycerides, Triethanolamine

DESCRIPTION:

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Gen7T Lotion is a prescription topical lotion containing 120 grams in a bottle. Lidocaine is present in

a 3.5% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl)

acetamide and has an empirical formula of C

H N O. The molecular weight of lidocaine is 234.34

g/mol.

The structural formulas are:

** Lidocaine**

CLINICAL PHARMACOLOGY:

Lidocaine is a topical anesthetic and stabilizes the neuronal membrane by inhibiting the ionic fluxes

required for the initiation and conduction of impulses, thereby effecting local anesthetic action.

CONTRAINDICATIONS:

Gen7T Lotion is contraindicated in patients with a known hypersensitivity to lidocaine, or any of the

topical amide-like local anesthetic preparations or to any other component of the product.

PRECAUTIONS:

Because of the possibility of sedation, patients should be cautioned regarding the operation of heavy

machinery or automobiles, and any activities made hazardous by decreased alertness.

Hepatic Disease: Patients with severe hepatic disease are at greater risk of developing toxic blood

concentrations of Lidocaine, because of their inability to metabolize Lidocaine normally.

Allergic Reactions: Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine,

benzocaine, etc.) have not shown cross sensitivity to Lidocaine. However, this product should be used

with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.

Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood

concentrations of Lidocaine from increased absorption. Gen7T Lotion

is only recommended for use

on intact skin.

Eye Exposure: The contact of this product with the eyes, although not studied, should be avoided

based on the findings of severe eye irritations with the use of similar products in animals. If eye contact

occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.

External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets,

over application area is not recommended as this has not been evaluated and may increase plasma

Lidocaine levels.

DRUG INTERACTIONS:

Antiarrhythmic Drugs: Gen7T Lotion

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 Lotion

is used concurrently with other products containing local

anesthetic agents the amount absorbed from all formulations must be considered.

CARCINOGENESIS, 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 topical lidocaine. The effect of Gen7T Lotion

fertility has not been studied.

PREGNANCY:

The safety of Gen7T Lotion has not been established during pregnancy. There are no well-

controlled studies in pregnant women. Gen7T Lotion

should not be used during pregnancy unless

absolutely needed and discussed with a physician.

NURSING MOTHERS:

The effect of Gen7T Lotion on the nursing infant has not been evaluated. Caution should be exercised

when Gen7T Lotion

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 Lotion 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 Lotion . 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.

HOW SUPPLIED:

Gen7T Lotion is supplied in the following dosage form:

120 grams

Made in USA

Rx Only

Manufactured for:

7T Pharma, LLC

220 Emerald Vista Way

Las Vegas, NV 89144

800.941.2848

NDC: 70645-627-35 Size: 120 grams

PRINCIPAL DISPLAY PANEL

NDC 70645-627-35

®

NDC 70645-627-35

GEN 7T Lotion

Rx Only

Lidocaine 3.5% Lotion

GEN7T

7T Pharma LLC

lidocaine lotion

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:70 6 45-6 27

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

3.5 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 6 45-6 27-35

120 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

UNAPPROVED DRUG OTHER

0 9 /0 1/20 19

Labeler -

7T Pharma LLC (080220022)

Revised: 9/2019

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