Search by Drug Name or NDC

NDC 69681-0432-10 Preboost 4 g/100mL Details

Preboost 4 g/100mL

Preboost is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Female Health Company d/b/a Veru Healthcare. The primary component is BENZOCAINE.

Product Information

NDC	69681-0432
Product ID	69681-432_036fa5d4-a566-486a-aa26-c9a3f01fbcfe
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Preboost
Proprietary Name Suffix	n/a
Non-Proprietary Name	benzocaine
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100mL
Substance Name	BENZOCAINE
Labeler Name	The Female Health Company d/b/a Veru Healthcare
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69681-0432-10 (69681043210)

Pricing Information	N/A
NDC Package Code	69681-432-10
Billing NDC	69681043210
Package	10 PACKET in 1 BOX (69681-432-10) / 1.2 mL in 1 PACKET
Marketing Start Date	2017-04-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 155e4ba2-7f06-454e-ae7e-e55ef8f891e3 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzocaine USP 4%

Purpose

Male Genital Desensitizer

Use

Helps in temporarily prolonging time until ejaculation

Warnings

Premature ejaculation may be due to a condition requiring medical supervision. If this product, used as directed, does not provide relief, discontinue use and consult a doctor.

Avoid contact with the eyes.
If you or your partner develops a rash or irritation, such as burning or itching, discontinue use.
If symptoms persist, consult a doctor.

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.

Inactives

Purified water, Ethyl Alcohol (SDA 40B), Propylene Glycol

PRINCIPAL DISPLAY PANEL - 10 Wipes Packet Box

Clinically Proven to Make Sex Last Longer

PREBOOST®

KEEP IT GOING

10 Single-Use Wipes

Male desensitizing wipes for

prolonging the time until ejaculation

H Fisch MD

Created by Dr. Harry Fisch, Named

"One of America's Best Doctors"

PRINCIPAL DISPLAY PANEL - 10 Wipes Packet Box

INGREDIENTS AND APPEARANCE

PREBOOST

benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69681-432
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
alcohol (UNII: 3K9958V90M)
water (UNII: 059QF0KO0R)
propylene glycol (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69681-432-10	10 in 1 BOX	04/05/2017
1		1.2 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/30/2015

Labeler - The Female Health Company d/b/a Veru Healthcare (055300578)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(69681-432)

Revised: 4/2017

Document Id: 036fa5d4-a566-486a-aa26-c9a3f01fbcfe

Set id: 155e4ba2-7f06-454e-ae7e-e55ef8f891e3

Version: 3

Effective Time: 20170407