Label: NUMB GEL ANESTHETIC- lidocaine hcl gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 17, 2022

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  • ACTIVE INGREDIENT

    Lidocaine HCl 4%

  • PURPOSE

    Topical anesthetic

  • INDICATIONS & USAGE

    Uses: For temporary relief of pain associated with minor skin procedures

  • WARNINGS

    For External Use only.

  • WHEN USING

    When using this product, do not use in or near the eyes • do not use in large quantities, particularly over raw surfaces or blistered areas. • do not use on puncture wounds • for more than one week without consulting a doctor

  • STOP USE

    Stop Use and ask a doctor if:

    • allergic reaction occurs
    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain or other symptoms begin or increase
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions: adults and children 2 years and older: apply to the affected area up to 3 to 4 times a day

    children under 2 years - ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin

  • OTHER SAFETY INFORMATION

    Store at 20 - 25 C (68 - 77 degrees F)

  • QUESTIONS

    Questions? 574-975-3632

  • PREGNANCY OR BREAST FEEDING

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

  • PRINCIPAL DISPLAY PANEL

    JAR LABEL AND BOX ART

    Numb box art

    Numb jar label

  • INGREDIENTS AND APPEARANCE
    NUMB GEL ANESTHETIC 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-595
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS1.12 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-595-021 in 1 BOX11/20/2020
    1NDC:76348-595-0128 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/20/2020
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    RENU LABORATORIES, INC.945739449manufacture(76348-595)
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