Label: RECTOPROTECT- lidocaine cream

  • NDC Code(s): 71399-0050-1, 71399-0050-2
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • Active ingredient

    Lidocaine 5% w/w

  • Purpose

    Local anesthetic

  • Uses

    temporarily relieves pain and itching due to anorectal disorders

  • Directions

    • when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth
    • before applying.
    • adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
    • children under 12 years of age: Consult a doctor
  • Warnings

    When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage unless directed by a doctor
  • Stop use and ask a doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs 
    • redness, irritation, swelling, pain or other symptoms begin or increase
    • symptoms clear up and return within a few days
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Other information

    • May be applied under occlusive dressing.
    • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
  • Inactive ingredients

    Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purifed Water, Trolamine and Vitamin E Acetate.

  • Questions or comments?

    Call toll-free 1-877-255-6999

    Manufactured for:

    Akron Pharma Inc.

    Fairfield, Nj 07004

    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    5-15-1

    5-15-2

    5-30-1

    5-30-2

  • INGREDIENTS AND APPEARANCE
    RECTOPROTECT 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    Colorwhite (clear gel) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0050-11 in 1 CARTON11/03/2023
    15 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:71399-0050-21 in 1 CARTON11/03/2023
    230 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/03/2023
    Labeler - Akron Pharma Inc. (067878881)
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