Label: TINA DAVIES ICECREAM- lidocaine hydrochloride, phenylephrine hydrochloride cream

  • NDC Code(s): 84313-001-05, 84313-001-30
  • Packager: TINA DAVIES PROFESSIONAL LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 30, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Lidocaine HCl 5%

    Phenylephrine HCl 0.25%

  • Purpose

    Local anesthetic

    Vasoconstrictor

  • Uses

    • For the temporary relief of anorectal itching and discomfort associated with hemorrhoids.
    • For temporary relief of pain.

  • Warnings

    For external use only
    Allergy alert:
    Certain persons can develop allergic reactions to ingredients in this product. The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
    Ask a doctor before use if
    • you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland.
    Ask a doctor or pharmacist before use if you
    • are presently taking a prescription drug for high blood pressure or depression.
    When using this product
    • do not exceed the recommended daily 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
    • Condition worsens or does not improve within 7 days.
    • Bleeding occurs.

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

  • Directions

    • Adults: 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 4 times daily.
    • Children under 12 years of age: consult a doctor.

  • Inactive ingredients

    Acetyl Hexapeptide-8, Butylene Glycol, Carboxymethyl Cellulose 2500, Chloroxylenol, Hexanediol CG, Pentapeptide-18, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Propylene Glycol, Sodium Hyaluronate, Water (Aqua).

  • SPL UNCLASSIFIED SECTION

    2-in-1 Maximum

    Strength Formula

    Hemorrhoidal cream

    with vasoconstrictor

    and local anesthetic

    Manufactured for Tina Davies Professional LLC

    1020 Holland Drive, Unit

    109 Boca Raton, FL 33487

    1-888-510-1388

    tinadavies.com

  • Packaging

    Tina Davies IceCreamTina Davies IceCream

  • INGREDIENTS AND APPEARANCE
    TINA DAVIES ICECREAM 
    lidocaine hydrochloride, phenylephrine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84313-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETYL HEXAPEPTIDE-8 AMIDE (UNII: L4EL31FWIL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    HEXANEDIOL (UNII: ZIA319275I)  
    PENTAPEPTIDE-18 (UNII: PO4D55T1IG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C12-14 ISOPARAFFIN (UNII: WP37Z9V66A)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84313-001-301 in 1 CARTON06/12/2024
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:84313-001-055 mL in 1 TUBE; Type 0: Not a Combination Product06/12/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01506/12/2024
    Labeler - TINA DAVIES PROFESSIONAL LLC (119265327)
    Establishment
    NameAddressID/FEIBusiness Operations
    THE SKINCARE FOUNDRY LTD230986608manufacture(84313-001)