United States - English - NLM (National Library of Medicine)
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.
7T Pharma, LLC
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
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
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.
Phenoxyethanol, Ethylhexylglycerin, Water, Glycerin, Disodium EDTA, Acrylates/C10-30 Alkyl
Acrylate Crosspolymer, Caprylic/Capric Triglycerides, Triethanolamine
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
The structural formulas are:
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.
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.
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
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
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.
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.
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.
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.
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.
Gen7T Lotion is supplied in the following dosage form:
Made in USA
7T Pharma, LLC
220 Emerald Vista Way
Las Vegas, NV 89144
NDC: 70645-627-35 Size: 120 grams
PRINCIPAL DISPLAY PANEL
GEN 7T Lotion
Lidocaine 3.5% Lotion
7T Pharma LLC
Product T ype
HUMAN PRESCRIPTION DRUG
Ite m Code (Source )
NDC:70 6 45-6 27
Route of Administration
Active Ingredient/Active Moiety
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)
3.5 g in 10 0 g
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)
Marketing Start Date
Marketing End Date
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
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
7T Pharma LLC (080220022)