Medication Guide App

Promescent

Dosage form: spray
Ingredients: Lidocaine 10g in 100g
Labeler: Absorption
NDC Code: 55636-590

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.

Promescent

Active Ingredient (per spray)

Lidocaine approx. 10mg

Purpose

Anesthetic

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Use:

Helps in temporarily slowing the onset of ejaculation.

Warnings:

​For external use only.

​Do not use if

  • You or your partner are allergic to lidocaine or topical anesthetics.
  • Your partner is, or may be pregnant.

​Ask a doctor or pharmacist before use if

  • You have liver problems.

​When using this product

  • Do not spray on broken, irritated or sensitive skin.
  • Avoid contact with the eyes.

​Stop use and ask a doctor

  • If you or your partner develop a rash or irritation, such as burning or itching, dicontinue use. If symptoms persist, consult a doctor.
  • 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. ​​

Directions:

Break front tab first. To unlock, press in special Child Resistant (R) tab in back of the actuator while turning the actuator to the right. Press the actuator down repeatedly until product dispenses to prime spray pump. Apply 3 or more sprays, not to exceed 10, to head and shaft of penis 10 minutes before sexual intercourse, or use as directed by a doctor. Recommended Initial Dosage: 3 sprays. Rub Promescent into the skin of the penis until all of the product is absorbed. Wash product off after intersourse. After spraying, turn actuator to the left to lock.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Dimethicone, Farnesol, Fragrance, Glycerin, Hydrogenated Polyisobutene, Macadamia Ternifolia Seed Oil, Panthenol, Phenoxyethanol, Purified Water (Aqua), SD Alcohol 40-B, Sodium Hydroxide, Soy Lecithin, Stearoxytrimethylsilane, Stearyl Alcohol, Thymol, Tocopheryl Acetate (Vitamin E).

Labeling

PROMESCENT 
lidicaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55636-590
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (LIDOCAINE) Lidocaine10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
GLYCERIN 
PANTHENOL 
CITRIC ACID MONOHYDRATE 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
DIMETHICONE 
HYDROGENATED POLYBUTENE (1300 MW) 
STEAROXYTRIMETHYLSILANE 
STEARYL ALCOHOL 
MACADAMIA OIL 
.ALPHA.-TOCOPHEROL ACETATE 
LECITHIN, SOYBEAN 
FARNESOL 
THYMOL 
ALCOHOL 
PHENOXYETHANOL 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:55636-590-741 BOTTLE, SPRAY in 1 CARTON
17.4 g in 1 BOTTLE, SPRAY
2NDC:55636-590-131 BOTTLE, SPRAY in 1 CARTON
21.3 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/11/2013
Labeler - Absorption (014937753)
Registrant - Ei Inc. (105803274)
Establishment
NameAddressID/FEIOperations
Ei Inc.105803274manufacture(55636-590), label(55636-590), pack(55636-590)

Revised: 01/2013
 
Absorption

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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