ROMAN SWIPES (BENZOCAINE) LIQUID [ROMAN HEALTH VENTURES INC.]

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ROMAN SWIPES (BENZOCAINE) LIQUID [ROMAN HEALTH VENTURES INC.]
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NDC 72484-433-03, 72484-433-08
Set ID 7f0eac8c-7235-99d8-e053-2a91aa0a634e
Category HUMAN OTC DRUG LABEL
Packager Roman Health Ventures Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzocaine USP 4%

  • PURPOSE

    Purpose

    Male Genital Desensitizer

  • INDICATIONS & USAGE

    Use

    Helps in temporarily prolonging time until ejaculation

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    Distributed by Roman Health Ventures, Inc.

    29 W 30th St. New York, NY 10001

    888-798-8686

  • PRINCIPAL DISPLAY PANEL

    ro

    ROMAN SWIPES

    FOR LONGER LASTING SEX

    8 INDIVIDUAL ENDURANCE WIPES

    72484-433 8CT

  • INGREDIENTS AND APPEARANCE
    ROMAN SWIPES 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72484-433
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72484-433-088 in 1 BOX01/10/2019
    11.2 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:72484-433-033 in 1 BOX01/10/2019
    21.2 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:72484-433-022 in 1 BOX12/17/2020
    31.2 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:72484-433-055 in 1 BOX12/17/2020
    41.2 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/10/2019
    Labeler - Roman Health Ventures Inc. (081317350)
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