MALE GENITAL DESENSITIZER STUD 100- lidocaine spray, metered 
D.D.D. 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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Active Ingredient                                                                                    Purpose

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

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. If swallowed get medical help or contact a Poison Control Center right away.

Stop and consult a doctor

if you or your partner develop a rash or irritation, such as burning or itching

if you do not 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 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 as directed by a doctor

-wash product after intercourse

-correct quantity and time of application will be determined by individual requirements and you should always use the minimum effective quantity

Inactive Ingredients

Fragrance, isopropyl myristate, solvent, stearic acid

carton

Stud 100 Male Genital Desensitizer Spray

The Delay Spray for Men

Active ingredient

Lidocaine Base USP

9.6% w/w 7/16 fl. oz.

MALE GENITAL DESENSITIZER  STUD 100
lidocane spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51115-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE9.6 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:51115-050-021 in 1 CARTON
1NDC:51115-050-01473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34803/13/201305/20/2013
Labeler - D.D.D. LTD (216339804)
Registrant - D.D.D. LTD (216339804)
Establishment
NameAddressID/FEIBusiness Operations
D.D.D. LTD216339804manufacture(51115-050)

Revised: 05/2013
Document Id: 825f4099-6827-4c93-bcee-f59ec7c3215e
Set id: 816676ee-6116-4cee-b610-001456dac38e
Version: 4
Effective Time: 20130520
 
D.D.D. LTD