STAG 9000 DELAYSPRAY FOR MEN- lidocaine spray

Stag 9000 DelaySpray for men by

Drug Labeling and Warnings

Stag 9000 DelaySpray for men by is a Otc medication manufactured, distributed, or labeled by LOTUSA LLC., FRENCH MALIHOME PERSONAL PRODUCTS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

1. Lidocaine 10.0% w/v (Approximately10 mgper spray)
2. Caprylic/ Capric Triglyceride,
3. Ethanol,
4. Isopropyl mrystate,
5. Tocopherol

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Lidocaine 10.0% w/v (Approximately10 mgper spray) Purpose: Male genital desensitizer

Purpose

Male genital desensitizer

Use

helps in the preventation of premature ejaculation

helps in temporarily prolonging thetime until ejaculation

for reducing oversensitivity in the male inadvance of intercourse

Warnings

For external use only. Avoid contact with the eyes.

Do not use

• on broken or inflamed skin

WHEN USING

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly withwater.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. Ifsymptoms persist, consult a doctor Ask a doctor before use

If your partner is pregnant or breast-feeding

If you have or have had liver or kidney problems. When using this pr oduct

do not get into eyes or nostrils

do not inhale

do not exceed a maximum of 6 sprays in 24 hours.

Always use the minimum amount effectivefor you

Allow5-15 minutes to dry prior to intercourse Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor This product is not compatible with condoms.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Use only as directed.
• Apply1-2 sprays, not to exceed 6, to the head and shaft ofthe penis before intercourse, peruse as directed by a doctor
• Wash product off after intercourse Please read the instructions for use and advice use carefully to achievebest results

Other information

• Store atroom temperature 20-25 o C (68-77 o F)

Inactive ingredients

Caprylic/ Capric Triglyceride, Ethanol, Isopropyl mrystate, Tocopherol

Package Label - Principal Display Panel

20 mL NDC: 80554-004-02

INGREDIENTS AND APPEARANCE

STAG 9000 DELAYSPRAY FOR MEN 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80554-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TOCOPHEROL (UNII: R0ZB2556P8)
ALCOHOL (UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80554-004-01	20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	03/30/2020

Labeler - LOTUSA LLC. (122415153)

Registrant - LOTUSA LLC. (122415153)

Establishment
Name	Address	ID/FEI	Business Operations
FRENCH MALIHOME PERSONAL PRODUCTS LIMITED		664283791	manufacture(80554-004)