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
  • 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 November 18, 2019

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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 finalpart34601/01/2016
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Registrant - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0980)
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