Promescent

Promescent

Drug Labeling and Warnings

Drug Details

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PROMESCENT- lidicaine spray 
Absorption

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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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

Label

Unit Carton

PROMESCENT 
lidicaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55636-590
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
MACADAMIA OIL (UNII: 515610SU8C)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
FARNESOL (UNII: EB41QIU6JL)  
THYMOL (UNII: 3J50XA376E)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55636-590-741 in 1 CARTON01/11/2013
17.4 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC: 55636-590-131 in 1 CARTON01/11/2013
21.3 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/11/2013
Labeler - Absorption (014937753)
Registrant - Swiss-American CDMO, LLC (080170933)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(55636-590) , label(55636-590) , pack(55636-590)

Revised: 3/2020
 
Absorption


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