![PREMJACT MALE DESENSITIZER POUND INTERNATIONAL (LIDOCAINE) SPRAY, METERED [FLEET LABORATORIES LTD]](https://medic.hrt.org//dailymed/images/b907b00b-356b-458f-a9ad-d3d167f4aa4c/can.jpg)
![PREMJACT MALE DESENSITIZER POUND INTERNATIONAL (LIDOCAINE) SPRAY, METERED [FLEET LABORATORIES LTD]](https://medic.hrt.org//dailymed/images/b907b00b-356b-458f-a9ad-d3d167f4aa4c/carton.jpg)
| NDC | 70233-004-01, 70233-004-02 |
| Set ID | b907b00b-356b-458f-a9ad-d3d167f4aa4c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | FLEET LABORATORIES LTD |
| Generic Name | |
| Product Class | Amide Local Anesthetic, Antiarrhythmic |
| Product Number | |
| Application Number | PART348 |
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ACTIVE INGREDIENT
Active Ingredient Purpose
Lidocaine Base USP 9.6% w/w (approximately 10 mg per spray) Topical Analgesic
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
Stop use 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 a maximum of 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 use as directed by a doctor
- Wash product off after intercourse
- correct quantity and time of application will be determined by individual requirements and you should always use the minimum effective quantity
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREMJACT MALE DESENSITIZER POUND INTERNATIONAL
lidocaine spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70233-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 9.6 g 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:70233-004-02 1 in 1 CARTON 05/09/2013 1 NDC:70233-004-01 12 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 not final part348 05/09/2013 Labeler - FLEET LABORATORIES LTD (217269489) Registrant - FLEET LABORATORIES LTD (217269489) Establishment Name Address ID/FEI Business Operations FLEET LABORATORIES LTD 217269489 manufacture(70233-004)
