Roman Male Genital Desensitizer

Roman by

Drug Labeling and Warnings

Roman by is a Otc medication manufactured, distributed, or labeled by Roman Health Ventures Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROMAN MALE GENITAL DESENSITIZER- benzocaine liquid 
Roman Health Ventures Inc.

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.

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Roman Male Genital Desensitizer

Drug Facts

Active ingredient

Benzocaine USP 4%

Purpose

Male Genital Desensitizer

Use

Helps in temporarily prolonging time until 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
• 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.

Inactive ingredients ethyl alcohol (SDA 40B), propylene glycol, purified water

Distributed by Roman Health Ventures, Inc.

29 W 30th St. New York, NY 10001

888-798-8686

ro

BENZOCAINE

MALE GENITAL DESENSITIZER

8 SINGLE USE ENDURANCE WIPES

ROMAN  MALE GENITAL DESENSITIZER
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72484-432
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72484-432-08	8 in 1 BOX	11/27/2018	12/31/2019
1		1.2 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 final	part348	11/27/2018	12/31/2019

Labeler - Roman Health Ventures Inc. (081317350)

Revised: 10/2019

Document Id: 9615543d-bb74-dd08-e053-2995a90ad277

34390-5

Set id: 7ba84a4c-79a8-86a6-e053-2a91aa0a8588

Version: 2

Effective Time: 20191029

 

Roman Health Ventures Inc.