Ombre Men Overtime Wipes Cloth
FDA Label NDC 54723-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sambria Pharmaceuticals, Llc for the product Ombre Men Overtime Wipes (NDC 54723-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, indication, warnings, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Benzocaine USP 7%

Purpose

Male Genital Desensitizer

Indication

For reducing oversensitivity in the male in advance of intercourse,

Warnings

For External Use only. Do not use onbroken or irritated skin.
When using this avoid contact with eyes.
Stop and ask doctor if:

  • the product, used as directed, does not provide relief. Premature ejaculation may be due to a condition requiring medical supervision.
  • you or your partner develop rash or irritation, such as burning or itching.
  • symptoms persist.

Keep Out Of Reach Of Children

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

Directions

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor. Wash product off after intercourse. Not suitable for oral use. Use as directed, not for use more than four times per day.

Inactive Ingredients

Lactic Acid, Phenol, Phenoxyethanol, Ethylhexylglycerin, Polyethylene Glycol, purified water

* Please review the disclaimer below.