MALE GENITAL DESENSITIZER STUD 100- lidocane spray, metered

Male Genital Desensitizer by

Drug Labeling and Warnings

Male Genital Desensitizer by is a Otc medication manufactured, distributed, or labeled by FLEET LABORATORIES LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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 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

PRINCIPAL DISPLAY PANEL

Stud 100 Male Genital Desensitizer Spray

The Delay Spray for Men

Active ingredient

Lidocaine Base USP

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

INGREDIENTS AND APPEARANCE

MALE GENITAL DESENSITIZER  STUD 100
lidocane spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70233-005
Route of Administration	TOPICAL

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: 70233-005-02	1 in 1 CARTON	03/13/2013
1	NDC: 70233-005-01	12.5 mL in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	03/13/2013

Labeler - FLEET LABORATORIES LTD (217269489)

Registrant - FLEET LABORATORIES LTD (217269489)

Establishment
Name	Address	ID/FEI	Business Operations
FLEET LABORATORIES LTD		217269489	manufacture(70233-005)