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Premjact Male Desensitizer Pound International

Medically reviewed on January 3, 2017

Dosage form: spray, metered
Ingredients: LIDOCAINE 9.6g in 100mL
Labeler: FLEET LABORATORIES LTD
NDC Code: 70233-004

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.

Premjact Male Genital Desensitizer Spray

Active Ingredient                                                                        Purpose

Lidocaine Base USP 9.6% w/w (approximately 10 mg per spray)    Topical Analgesic

Use temporarily reduces sensitivity of the penis, which helps to delay ejaculation in cases of over-rapid or premature ejaculation (coming to a climax too quickly

Keep out of reach of children

Stop use and consult a doctor

  • if you or your partner develop a rash or irritation, such as burning or itching
  • If you do feel unwell or have any unpleasant effects after using the spray
  • if this product, used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision.

Warnings

For external use only

Allergy alert: do not use this product if you or your partner are allergic (sensitive) to local anesthetics

Do not use

  • on broken or inflamed skin
  • if your partner is pregnant

Ask a doctor before use if you have, or ever had, liver or kidney problems

Ask a doctor or pharmacist before use if you are already taking prescribed drugs

When using this product

  • do not get into eyes
  • do not inhale
  • do not exceed a maximum of 24 sprays in 24 hours

directions

  • Apply 3 or more sprays, not to exceed 10, to the head and shaft of the penis before intercourse or use as directed by a doctor
  • Wash product off after intercourse
  • correct quantity and time of application will be determined by individual requirements and you should always use the minimum effective quantity

There are no inactive ingredients

Premjact

Male Genital Desensitizer Spray

7/16 Fl.Oz.

PREMJACT MALE DESENSITIZER  POUND INTERNATIONAL
lidocaine spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70233-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE9.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:70233-004-021 CAN in 1 CARTON
1NDC:70233-004-0112 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/09/2013
Labeler - FLEET LABORATORIES LTD (217269489)
Registrant - FLEET LABORATORIES LTD (217269489)
Establishment
NameAddressID/FEIOperations
FLEET LABORATORIES LTD217269489manufacture(70233-004)

 
FLEET LABORATORIES LTD

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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