Label: ANORECTAL EQUATE- lidocaine cream

  • 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 December 29, 2017

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  • Active ingredient                               Purpose


    Lidocaine 5%......................................Local anesthetic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses For temporary relief of pain, soreness and burning.

  • Warnings For external use only

    When using this product do not get into eyes.
    Stop use and ask a doctor if • condition worsens or does
    not improve within 7 days • do not exceed the
    recommended daily dosage unless directed by a doctor
    • in case of bleeding, consult a doctor promptly • do not
    put this product into the rectum by using fingers or any
    mechanical device or applicator

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

  • SPL UNCLASSIFIED SECTION

  • SPL UNCLASSIFIED SECTION

  • DOSAGE & ADMINISTRATION

    Directions Apply externally to affected area up to 6
    times daily.

  • OTHER SAFETY INFORMATION

    Other information Store at 25° C (77° F);
    excursions permitted to 15-30˚ C (59-86˚ F).

  • INACTIVE INGREDIENT

    Inactive ingredients
    Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ANORECTAL   EQUATE
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-655
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-655-011 in 1 CARTON04/16/2016
    129.6 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/16/2016
    Labeler - Walmart (051957769)
    Registrant - Product Quest (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest927768135manufacture(49035-655) , label(49035-655)
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