Label: ALLEGENAL-M- benzocaine cream

  • NDC Code(s): 69524-555-01
  • Packager: Halal Nutritional Center
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated February 22, 2017

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Benzocaine - USP 7.50% ....

  • Purpose

    Male Genital Desensitizer

  • Uses:

    Helps in the prevention of premature 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.
    • If you or your partner develop a rash or irritation, such as burning or itching, discontinue use. If symptoms persist, consult a doctor.
  • Keep out of reach of children.

    Avoid contact with eyes.

  • Directions:

    Apply a small amount to head and shaft of penis before intercourse. Wash product off after intercourse.

  • Other Ingredients:

    Acrylates Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aqua (Deionized Water), C13-14 Isoparaffin, Dehydroepiandrosterone (Dhea), Diazolidinyl Urea, Dimethicone, Isopropyl Myristate, Laureth-7, Methyl Paraben, Panax Ginseng Root Extract, Peg-8, Polyacrylamide, Propylene Glycol, Propyl Paraben, Triethanolamine.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Hala Nutritional Center (HNC),

    1707 1/2 post Oak Blvd., # 260, Houston, TX 77056,

    Toll free: (888) 672-1075, Tel:+1-713-626-7177

    website:www.myhalacenter.com

  • Package Label

    HNC

    Allegenal M

    Prevention of Premature Ejaculation

    Nt. wt. 2oz

    AllegenalMLabel

  • INGREDIENTS AND APPEARANCE
    ALLEGENAL-M 
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69524-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    7-KETO-DEHYDROEPIANDROSTERONE (UNII: 2334LJD2E9)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69524-555-0156.7 g in 1 JAR; Type 0: Not a Combination Product02/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/28/2015
    Labeler - Halal Nutritional Center (078408264)