Label: BLISS REPUBLIC LIDOCAINE NUMBING CREAM- lidocaine numbing cream cream

  • NDC Code(s): 84028-111-11, 84028-111-12, 84028-111-13
  • Packager: Sargass Group Limited Liability Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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

  • Active Ingredient(s)

    LIDOCAINE 5%_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Local Anesthetic

  • Purpose

    Topical Anesthetic

  • Use

    For temporary relief of local and anorectal discomfort, itching, pain, soreness, or burning associated with anorectal disorder or inflammation.

  • Warnings

    (For external use only)

    Before usage:

    Avoid using this product if you have a known allergy to lidocaine.
    Do not use while pregnant or breastfeeding.

    In case of accidental overdose, seek immediate medical assistance or contact the Poison Control Center.

  • WHEN USING

    When using this product:

    Adhere to the recommended daily dosage unless otherwise directed by a doctor.
    Some individuals with heightened sensitivity might experience allergic reactions to specific ingredients in this product.

    Do not insert this cream into the rectum using fingers, applicators, or any medical devices.

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children. Avoid contact with eyes. In case of accidental ingestion, seek medical attention immefiately.

  • STOP USE

    Discontinue use and consult a doctor if:

    The treated symptoms show no signs of improvement, or if redness, irritation, swelling, pain, or other symptoms manifest or worsen. Seek immediate medical attention in such cases.

  • Directions

    Adults: Before applying this product, gently dry the application area by patting or blotting it with toilet tissue or a clean, soft cloth.

    Apply up to 6 times daily. Children under 12 years: consult a doctor.

  • Other information

    Additional Information:

    Store at room temperature. Avoid direct sunlight. Refrain from using if packaging has been damaged or is missing.

  • Inactive ingredients

    Carbomer 934, Arnica, Emu oil, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate (Vitamin E), Benzyl Alcohol, Menthol, Water Floral scent

  • Package Label - Principal Display Panel

    Cream-label30mL NDC: 84028-111-11

  • INGREDIENTS AND APPEARANCE
    BLISS REPUBLIC LIDOCAINE NUMBING CREAM 
    lidocaine numbing cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84028-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84028-111-1130 mL in 1 JAR; Type 0: Not a Combination Product01/03/2024
    2NDC:84028-111-1255 mL in 1 JAR; Type 0: Not a Combination Product01/03/2024
    3NDC:84028-111-13100 mL in 1 JAR; Type 0: Not a Combination Product01/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/03/2024
    Labeler - Sargass Group Limited Liability Company (119155798)