Label: RECTICARE- lidocaine and glycerin cloth

  • NDC Code(s): 0496-0980-65, 0496-0980-76
  • Packager: Ferndale Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active Ingredients

    Lidocaine 5% w/w

    Glycerin 20% w/w

  • Purpose

    Lidocaine 5% w/w........................................Local anesthetic

    Glycerin 20% w/w.........................................Protectant

  • Uses

    • helps relieve the pain, itching and burning associated with anorectal disorders
    • temporarily provides a coating for relief of anorectal discomforts
    • temporarily protects irritated and inflamed perianal skin
  • Warnings

    For external use only

    Do not

    • exceed the recommended daily dosage unless directed by a doctor
    • put this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • an allergic reaction develops
    • condition worsens or does not improve witin 7 days
    • redness, irriation, swelling, pain or other symptoms begin or increase
    • bleeding occurs

    Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center right away.

  • Directions

    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroghly
    • gently apply wipe to the affected area by patting and then discard
    • adults and children 12 years & older: apply up to 6 times daily - or after each bowel movement
    • children under 12 years: consult a doctor

  • Inactive Ingredients

    benzyl alcohol, citric acid, purified water

  • Package Label

    frontpouch

    pouchback

  • INGREDIENTS AND APPEARANCE
    RECTICARE 
    lidocaine and glycerin cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0980
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0496-0980-6512 in 1 CARTON01/01/2016
    1NDC:0496-0980-766 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/01/2016
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Registrant - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0980)
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