Label: EQUATE HEMORRHOID RELIEF- lidocain 5% 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 August 31, 2022

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  • ACTIVE INGREDIENT

    Lidocaine 5% W/W

  • PURPOSE

    Local Anesthetic

  • USES

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

  • WARNINGS

    For external use only

    When using this product

    • use only as directed
    • 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
    • symptoms clear up and occur again within a few days
    • an allergic reaction develops to ingredients in this product
    • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children and pets.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • DIRECTIONS

    Adult and children 12 years and over:

    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • apply externally to the affected area up to 6 times a day

    children under 12 years of age: consult a doctor.

  • OTHER INFORMATION

    Store between 15°-30° C (59°-30° F)

  • INACTIVE INGREDIENTS

    Benzyl Alcohol, Carbomer 940, Cholesterol, Isopropyl Myristate, Lecithin (Soya), Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin-E Acetate

  • QUESTIONS

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    EQUATE HEMORRHOID RELIEF 
    lidocain 5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-109-301 in 1 CARTON04/01/2022
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/01/2022
    Labeler - WALMART, INC (051957769)
    Registrant - GURUNANDA, LLC (079671169)
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