MAX 4 MEN - MAX CONTROL MALE SEX PROLONG UNSCENTED (BENZOCAINE) GEL [WTFN INC. DBA CLASSIC EROTICA]

MAX 4 MEN - MAX CONTROL MALE SEX PROLONG UNSCENTED (BENZOCAINE) GEL [WTFN INC. DBA CLASSIC EROTICA]
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NDC 60886-101-11
Set ID fd417d43-1f15-4142-a428-952b9ab05411
Category HUMAN OTC DRUG LABEL
Packager WTFN INC. DBA CLASSIC EROTICA
Generic Name
Product Class
Product Number
Application Number PART348
  • 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

    Max Control Gel_Product Image

    Max Control Gel_Drug Facts Box

  • INGREDIENTS AND APPEARANCE
    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)

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