STAG 9000 DELAYSPRAY FOR MEN - Lidocaine Spray

LOTUSA LLC.

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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STAG 9000 DELAY SPRAY FOR MEN
Lidocaine 10.0% w/v (Approximately10 mgper spray)
Caprylic/ Capric Triglyceride,
Ethanol,
Isopropyl mrystate,
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 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 effective for you
  • Allow 5-15 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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
  • 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

 

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)