MAX 4 MEN - MAX CONTROL MALE SEX PROLONG UNSCENTED- benzocaine gel

MAX 4 MEN - MAX CONTROL MALE SEX PROLONG by

Drug Labeling and Warnings

MAX 4 MEN - MAX CONTROL MALE SEX PROLONG by is a Otc medication manufactured, distributed, or labeled by WTFN INC. DBA CLASSIC EROTICA, Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT:

Benzocaine 5%

PURPOSE:

Male Genital Desensitizer
Topical Anesthetic

USES:

Temporarily reduces oversensitivity of the penis, which helps in the prevention of premature ejaculation.

WARNING:

For External Use Only.

Do Not Use:
on broken or inflamed skin
if partner is pregnant
on large areas of the body and/or orally

When Using This Product

• Apply to Penile Area Only
• Avoid Contact with Eyes.
• If Irritation Occurs, Discontinue Use
• Do Not Use More Than Directed

Stop use and consult a doctor
If you or your partner develop a rash or irritation such as burning or itching
If this product, used as directed, does not provide relief. Premature Ejaculation may be due to a condition requiring medical supervision.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach out children. If swallowed, seek medical assistance or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

Allergy Alert: do not use if you have a known hypersensitivity (allergy) to any of the ingredients or are sensitive to local anesthetics

DIRECTIONS:

Apply a small amount to head and shaft of penis before intercourse, or use as directed by a doctor. You should always use the minimum effective quantity.

OTHER INFORMATION:

Store at temperature 20°-25° C or 68° -77° F

INACTIVE INGREDIENTS:

Butylene Glycol, Citric Acid, Glycereth-26, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Tuarate Copolymer, Polysorbate 20, Polysorbate 60, Potassium Sorbate, Squalane, Water (Eau/Aqua)

QUESTIONS OR COMMENTS:

Call us at 800.497.7749 M-F 9am -5pm PST or visit our website at www.classicerotica.net

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAX 4 MEN - MAX CONTROL MALE SEX PROLONG  UNSCENTED
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60886-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SQUALANE (UNII: GW89575KF9)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60886-101-11	15 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/11/2018

Labeler - WTFN INC. DBA CLASSIC EROTICA (063659117)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd		017701475	manufacture(60886-101)