Label: PROMESCENT- lidicaine spray
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated January 16, 2013
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- Active Ingredient (per spray)
- Keep out of reach of children
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.
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.
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).
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55636-590 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine 10 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:55636-590-74 1 in 1 CARTON 1 7.4 g in 1 BOTTLE, SPRAY 2 NDC:55636-590-13 1 in 1 CARTON 2 1.3 g in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 01/11/2013 Labeler - Absorption (014937753) Registrant - Ei Inc. (105803274) Establishment Name Address ID/FEI Business Operations Ei Inc. 105803274 manufacture(55636-590) , label(55636-590) , pack(55636-590)