PREMJACT MALE DESENSITIZER POUND INTERNATIONAL- lidocaine spray, metered 
Pound International

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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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

can

carton

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:57707-058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE9.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57707-058-021 in 1 CARTON05/09/2013
1NDC:57707-058-0112 mL in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/09/2013
Labeler - Pound International (802685065)
Establishment
NameAddressID/FEIBusiness Operations
FLEET LABORATORIES LTD217269489manufacture(57707-058)

Revised: 1/2019
Document Id: 312a8ad4-5a68-419a-ab9e-6fc4301b6351
Set id: 3e9f369c-3361-467a-907a-52295baeb3ea
Version: 9
Effective Time: 20190110
 
Pound International