Label: SECONDARY NUMB LIDOCAINE PHENYLEPHRINE GEL- lidocaine, phenylephrine hydrochloride gel

  • NDC Code(s): 83120-378-00
  • Packager: LALANI Rx Consulting, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active ingredients (w/w)

    Lidocaine 5% Phenylephrine HCL 0.25%

    Purpose

    Local Anesthetic

    Vaso Constrictor

  • Uses

    • Temporary relief of pain • Temporarily shrinks hemorrhoidal tissue • For the temporary relief of anorectal discomfort associated with hemorrhoids

  • Warnings

    For external use only

    Do not use

    if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination

    Ask a doctor before use if you are

    • presently taking medicine for high blood pressure or depression

    When using this product

    • do not put it into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • bleeding occurs • condition worsens or does not improve within 7 days • redness, irritation, swelling, pain or other symptoms occur. If allergic  reaction to product occurs.

    Keep out of reach of children.

    If swallowed, call poison control centre or get medical help right away

  • Directions

    Adults and children 12 years and over: • Children under 12 consult a doctor • Cleanse the affected area with mild soap and warm water. Rinse well or pat with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying this product • Apply to the affected area up to 3 times daily • Do not use more often than directed



  • Inactive ingredients

    Aminomethylpropanol, Aqua, Benzyl Alcohol, Caprylyl Glycol, Carbomer, Phenoxyethanol, Propylene Glycol

  • Questions?

    1-844-782-2387

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SECONDARY NUMB LIDOCAINE PHENYLEPHRINE GEL 
    lidocaine, phenylephrine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83120-378
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83120-378-001 in 1 BOX10/10/2022
    131.18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01510/10/2022
    Labeler - LALANI Rx Consulting, Inc. (243276725)
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