Label: PREMJACT MALE DESENSITIZER POUND INTERNATIONAL- lidocaine spray, metered
-
Contains inactivated NDC Code(s)
NDC Code(s): 57707-058-01, 57707-058-02 - Packager: Pound International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 10, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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
-
INGREDIENTS AND APPEARANCE
PREMJACT MALE DESENSITIZER POUND INTERNATIONAL
lidocaine spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57707-058 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:57707-058-02 1 in 1 CARTON 05/09/2013 1 NDC:57707-058-01 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 - Pound International (802685065) Establishment Name Address ID/FEI Business Operations FLEET LABORATORIES LTD 217269489 manufacture(57707-058)
