MALE GENITAL DESENSITIZER STUD 100- lidocaine spray, metered 
Pound International Corp

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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Stud 100 Male Desensitizer

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 spanish

carton

Can

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 Type HUMAN OTC DRUG Item Code (Source) NDC:57707-050
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 9.6 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57707-050-02 1 in 1 CARTON
1 NDC:57707-050-01 473 mL in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/13/2013
Labeler - Pound International Corp (802685065)
Registrant - FLEET LABORATORIES LTD (217269489)
Establishment
Name Address ID/FEI Business Operations
FLEET LABORATORIES LTD 217269489 manufacture(57707-050)

Revised: 1/2015
Document Id: c9bbe1e3-c350-494a-92c8-48a3d1e5a4be
Set id: d075656e-b13f-4a1d-bbb6-501e642698d5
Version: 9
Effective Time: 20150112
 
Pound International Corp