Label: LIDOCAINE HCL 4% cream

  • 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 June 22, 2021

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  • Active Ingredient:

    Lidocaine HCl 4% w/w

  • Purpose

    Topical anesthetic

  • Uses

    temporarily relieves pain and itching due to:

    • minor cuts
    • minor scrapes
    • sunburn
    • minor skin irritations
    • minor burns
    • insect bites
  • WARNINGS

    For external use only.

    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

    Stop use and ask 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.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
    • Children under 2 years of age: Consult a doctor.
  • Other Information

    Store at USP controlled room temperature 20-25 °C (68-77 °F).

  • Inactive ingredients

    benzyl alcohol, carbomer 940, BHT, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopherol acetate, trolamine, water

    Questions or comments?

    1-855-361-3993

    Manufactured for:

    AvKARE

    Pulaski, TN 38478

  • Lidocaine HCl 4% 10 x 5 g Tube

    30

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HCL 4% 
    lidocaine hcl 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-490
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-490-301 in 1 CARTON06/22/2021
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/22/2021
    Labeler - AvPAK (832926666)
    Registrant - Denison Pharmaceuticals (001207208)
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