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

  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

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 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

Other information

Inactive ingredients

Caprylic/ Capric Triglyceride, Ethanol, Isopropyl mrystate, Tocopherol

Package Label - Principal Display Panel

20 mL NDC: 80554-004-02

20 ml

STAG 9000 DELAYSPRAY FOR MEN 
lidocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80554-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALCOHOL (UNII: 3K9958V90M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80554-004-0120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34803/30/2020
Labeler - LOTUSA LLC. (122415153)
Registrant - LOTUSA LLC. (122415153)
Establishment
NameAddressID/FEIBusiness Operations
FRENCH MALIHOME PERSONAL PRODUCTS LIMITED664283791manufacture(80554-004)

Revised: 9/2020
Document Id: b0018ffc-2891-e40e-e053-2a95a90a42c1
Set id: b001d60e-b8f8-54ff-e053-2a95a90a2970
Version: 1
Effective Time: 20200923
 
LOTUSA LLC.