Promescent

Promescent
SPL v11
SPL
SPL Set ID 5b508238-3be7-4b0d-bf35-51de79f58f55
Route
TOPICAL
Published
Effective Date 2023-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (10 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Lidocaine approx. 10mg

Purpose

Anesthetic


Medication Information

Purpose

Anesthetic

Description

Lidocaine approx. 10mg

Use:

Helps in temporarily slowing the onset of ejaculation.

Labeling

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).

Active Ingredient (per Spray)

Lidocaine approx. 10mg

Keep Out of Reach of Children

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


Structured Label Content

Use:

Helps in temporarily slowing the onset of ejaculation.

Purpose

Anesthetic

Labeling

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).

Active Ingredient (per Spray) (Active Ingredient (per spray))

Lidocaine approx. 10mg

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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