MAX 4 MEN - MAX CONTROL MALE SEX PROLONG UNSCENTED- benzocaine gel 
WTFN INC. DBA CLASSIC EROTICA

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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CLASSIC EROTICA - MAX 4 MEN - MAX CONTROL MALE SEX PROLONG GEL - UNSCENTED

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

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

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

Max Control Gel_Product Image

Max Control Gel_Drug Facts Box

MAX 4 MEN - MAX CONTROL MALE SEX PROLONG  UNSCENTED
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60886-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60886-101-1115 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/11/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/11/2018
Labeler - WTFN INC. DBA CLASSIC EROTICA (063659117)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd017701475manufacture(60886-101)

Revised: 3/2018
Document Id: 1834c030-1039-4889-8ae5-ac0cab201cc9
Set id: fd417d43-1f15-4142-a428-952b9ab05411
Version: 2
Effective Time: 20180316
 
WTFN INC. DBA CLASSIC EROTICA