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RECTICARE (Ferndale Laboratories, Inc.)

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CREAM 30 g in 1 TUBE (0496-0892-30) Label Information

Complete RECTICARE Information

  • Active ingredient

    Lidocaine 5% w/w


  • Purpose

    Local anesthetic


  • Uses

    Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.


  • Warnings

    For external use only.

    When using this product
    • avoid contact with eyes
    • do not exceed recommended dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator


    Stop use and ask a doctor if
    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs to ingredients in this product
    • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
    • symptoms clear up and return within a few days


    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.


  • 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.
    • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.



  • Other Information

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].


  • Inactive Ingredients

    benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate


  • Package Label

    Manufactured for Ferndale Healthcare® Inc.

    By Ferndale Laboratories, Inc.

    Ferndale, MI 48220 U.S.A.

    Toll free (888) 548-0900

    www.ferndalehealthcare.com

    15 grams (NDC 0496-0892-15)

    15gCartonRev05-14



    30 grams (NDC 0496-0892-30)

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  • INGREDIENTS AND APPEARANCE
    RECTICARE 
    lidocaine cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0496-0892
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0496-0892-30 30 g in 1 TUBE; Type 0: Not a Combination Product 03/09/2012
    2 NDC:0496-0892-15 15 g in 1 TUBE; Type 1: Convenience Kit of Co-Package 01/19/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 03/09/2012
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    Name Address ID/FEI Business Operations
    Ferndale Laboratories, Inc. 005320536 manufacture(0496-0892)