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Prolayed

Dosage form: ointment
Ingredients: LIDOCAINE 10mg in 1mL
Labeler: ViaDerma, Inc
NDC Code: 69006-010

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.

Prolayed

Drug Facts

Active ingredient (in each spray)

Lidocaine 10 mg

Purpose

Male genital desensitizer

Use

Helps in temporarily slowing the onset of ejaculation.

Warnings

For external use only

When using this product
  • avoid contact with the eyes.

Stop use and ask a doctor if
  • this product, used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision
  • you or your partner develop a rash or irritation, such as burning or itching.

Keep out of reach of children.

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

Directions
  • Apply 3 or more sprays, not to exceed 10, to head and shaft of penis before intercourse, or use as directed by a doctor.
  • Wash product off after intercourse.

Inactive ingredients

acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxyethylcellulose, magnesium stearate, methylparaben, sodium hydroxide, sorbic acid, stearic acid, water

Package Labeling:

PROLAYED 
lidocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69006-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID 
ASCORBIC ACID 
CHLORHEXIDINE GLUCONATE 
CHOLECALCIFEROL 
DIMETHYL SULFOXIDE 
DIPROPYLENE GLYCOL 
GLUCONOLACTONE 
GLYCERIN 
HISTIDINE 
MAGNESIUM STEARATE 
METHYLPARABEN 
SODIUM HYDROXIDE 
SORBIC ACID 
STEARIC ACID 
WATER 
Packaging
#Item CodePackage Description
1NDC:69006-010-0015 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B06/23/2017
Labeler - ViaDerma, Inc (079387584)

Revised: 12/2017
 
ViaDerma, Inc

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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