PROMESCENT- lidicaine spray

Promescent by

Drug Labeling and Warnings

Promescent by is a Otc medication manufactured, distributed, or labeled by Absorption, Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PROMESCENT 
lidicaine spray

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	01/11/2013
1		7.4 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 55636-590-13	1 in 1 CARTON	01/11/2013
2		1.3 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 55636-590-26	1 in 1 CARTON	01/11/2013
3		3.8 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
4	NDC: 55636-590-52	1 in 1 CARTON	01/11/2013
4		5.4 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

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 - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(55636-590) , label(55636-590) , pack(55636-590)