Ombre Men overtime wipes

Manufacturer: Sambria Pharmaceuticals, LLC
Effective date: 2025-10-07
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:39:18

Label at a glance#

ProductOmbre Men overtime wipes

Active ingredientBENZOCAINE

Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine USP 7%

Purpose

OTC - PURPOSE SECTION

Male Genital Desensitizer

Indication

INDICATIONS & USAGE SECTION

For reducing oversensitivity in the male in advance of intercourse,

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED SECTION

For Questions or Comments, visit our website OMBREMEN.COM

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54723-007-01	Ombre Men overtime wipes	3 mL in 1 PACKET	CLOTH	3		3
54723-007-01	Ombre Men overtime wipes	10 in 1 PACKAGE	CLOTH	10		3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Ombre Men overtime wipes
Benzocaine
WATER
LACTIC ACID, UNSPECIFIED FORM
PHENOL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54723-007	54723-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
LACTIC ACID, UNSPECIFIED FORM	33X04XA5AT	IACT
PHENOL	339NCG44TV	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
BENZOCAINE	U3RSY48JW5	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2024-01-17	full-release	2026-06-01 00:07:55

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ombre Men overtime wipes	BENZOCAINE	Sambria Pharmaceuticals, LLC	405f23ca-99c1-4db4-aba1-2fd7f93f55ee	2025-10-07	Warnings	Exact identifier ndc (package): 54723-007-01 ndc (product): 54723-007 ndc11 (package): 54723000701 spl id: 40923488-6a65-15ce-e063-6294a90a6e36 spl set id: 405f23ca-99c1-4db4-aba1-2fd7f93f55ee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.