OMBRE MEN OVERTIME WIPES- benzocaine cloth

Ombre Men overtime wipes by

Drug Labeling and Warnings

Ombre Men overtime wipes by is a Otc medication manufactured, distributed, or labeled by Sambria Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

For Questions or Comments, visit our website OMBREMEN.COM

Inactive ingredients

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

Product label

INGREDIENTS AND APPEARANCE

OMBRE MEN OVERTIME WIPES 
benzocaine cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
PHENOL (UNII: 339NCG44TV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54723-007-01	10 in 1 PACKAGE	01/01/2022
1		3 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2022

Labeler - Sambria Pharmaceuticals, LLC (078676259)