Label: HEMPORRHOID- lidocaine hcl cream

  • NDC Code(s): 76348-590-01, 76348-590-02
  • Packager: Renu Laboratories, Inc.
  • 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 January 14, 2022

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  • STATEMENT OF IDENTITY

    Hemorrhoidal Cream

  • ACTIVE INGREDIENT

    Lidocaine HCl 5%

  • PURPOSE

    Topical Anesthetic

  • Uses

    For the temporary relief of

    • Pain
    • Itching
    • Burning associated with inflamed hemorrhoidal tissues
  • WARNINGS

    For external use only

  • WHEN USING

    When using this product

    • Keep out of eyes. Rinse with water to remove. Do not use in large quantities, particularly over raw surfaces or blistered areas.
  • STOP USE

    Stop use and ask a doctor if conditions worsen, or, if symptoms persist for more than 7 days, or clear up and occur again within a few days. Discontinue use of this product and consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

    If pregnant or breast-feeding, ask a health professional before use.

  • Directions:

    Adults and children 2 years of age and older: apply to affected area not more than 3 - 4 times daily.

    Children under 2 years of age: Consult a doctor.

  • OTHER SAFETY INFORMATION

    Other information: Store between 58 - 87° F

    Protect from freezing, direct heat or sunlight.

  • QUESTIONS

    Questions? www.marswellness.com

    Mars Wellness

    Lakewood, NJ 08701

  • INACTIVE INGREDIENT

    INGREDIENTS: Capryl Glycol, Caprylic / Capric Triglyceride, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin, Hemp Extract with proprietary Terpene blend: (Beta Caryophyllene, Humulene, Limonene, Myrcene, Linalool, Nerolidol, Beta Pinene, Alpha Pinene, Eucalyptol), Hexylene Glycol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol.

  • PRINCIPAL DISPLAY PANEL

    HEMPORRHOID TUBE ART

    Hemporrhoid 1.0 oz. tube art

  • INGREDIENTS AND APPEARANCE
    HEMPORRHOID 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-590
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS1.4 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    .BETA.-PINENE (UNII: 4MS8VHZ1HJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    HUMULENE (UNII: 54W56MD2WD)  
    MYRCENE (UNII: 3M39CZS25B)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    .ALPHA.-PINENE (UNII: JPF3YI7O34)  
    NEROLIDOL (UNII: QR6IP857S6)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    JOJOBA OIL (UNII: 724GKU717M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-590-021 in 1 BOX11/23/2020
    1NDC:76348-590-0128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/23/2020
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-590)
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