Sanoba by Myungmoon Pharm. Co.,Ltd
Sanoba by
Drug Labeling and Warnings
Sanoba by is a Otc medication manufactured, distributed, or labeled by Myungmoon Pharm. Co.,Ltd. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
SANOBA- lidocaine spray
Myungmoon Pharm. Co.,Ltd
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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INACTIVE INGREDIENT
Inactive Ingredients: Isopropyl Myristate, Stearic Acid, Diethylene Glycol Ethyl Ether, Tetrafluoro Ethane
WARNINGS
Warnings and Precautions: - Discontinue use if a rash or irritation develops. - If symptoms persist consult a doctor. - Wash off after intercourse. - Do not spray in eyes or nostrils. - For external use only. - If you have liver or kidney failure, consult your doctor before using this product. - Keep medicines away from children.
INDICATIONS & USAGE
Indications and usage: To reduce tactile sensitivity of the penis in advance of intercourse as a means of delaying ejaculation in cases of over-rapid or precipitant ejaculation. Adults 7-18 sprays (23-62 mg lidocaine base) applied to the glans and shaft of the penis 5 to 15 minutes prior to intercourse.
DOSAGE & ADMINISTRATION
Dosage and Administration: Adults 7-18 sprays (23-62 mg lidocaine base) applied to the glans and shaft of the penis 5 to 15 minutes prior to intercourse. Quantity and advance timing will be determined by individual requirements. The minimum effective dose should be used. The maximum dose should not exceed 53 sprays (184 mg lidocaine base) in 24 hours. The product should not be used repeatedly for more than 3 months without medical supervision
Children: Not applicable Elderly: Not recommended
INTERACTIONS
Interaction: Reports of interactions have been associated generally with systemic administration of lidocaine which results in high blood concentrations. The systemic uptake of lidocaine from SANOBA is unlikely to be sufficient to produce interactions. Interactions have been reported with antiarrhythmic agents, anticonvulsants, anticholinergic agents, antihypertensives, barbiturates, beta-blockers, muscle relaxants and sympathomimetic agents. Interactions with diagnostic tests for serum enzymes have also been reported.
Pregnancy and lactation
Pregnancy and lactation: SANOBA is only indicated for use in males. However, possible transfer of lidocaine to the female partner could occur during intercourse. Whilst there is no, or inadequate, evidence of safety of lidocaine in human pregnancy, it has been in widespread use without apparent adverse effects. Animal studies have shown no hazard. At the proposed male dose, the systemic availability of lidocaine to the female partner is unlikely to result in any adverse effects. Use of SANOBA should be avoided if the female is pregnant.
OVERDOSAGE
Overdose: Overdose of lidocaine with SANOBA is unlikely due to the small container size and low systemic availability of lidocaine following topical application. Signs of overdosage of lidocaine include stimulation and/or depression of the CNS. Treatment is symptomatic.
OTHER SAFETY INFORMATION
Undesirable effects: In extremely rare cases local anaesthetic preparations have been associated with allergic reactions. Occasional local skin irritation may occur following the use of SANOBA. Systemic adverse reactions to lidocaine are usually the result of high plasma concentrations due to high dosage, rapid absorption or may result from hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Such reactions involve excitatory and/or depressant actions on the CNS characterised by nervousness, dizziness, convulsions, unconsciousness and possible respiratory arrest. Cardiovascular reactions are depressant and may include hypotension, myocardial depression, bradycardia and possibly cardiac arrest. The plasma lidocaine levels attained following application of SANOBA at the maximum recommended dose are extremely low at about 25 times lower than the concentrations associated with systemic toxicity.
Shelf life: Three (3) years.
Storage Condition Hermetic, light resistant, moistureproofing container Room temperature
| SANOBA
lidocaine spray |
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| Labeler - Myungmoon Pharm. Co.,Ltd (687804328) |
| Registrant - Myungmoon Pharm. Co.,Ltd (687804328) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Myungmoon Pharm. Co.,Ltd | 687804328 | manufacture(70946-010) | |