Label: LIDOCAINE PAIN RELIEF- lidocaine hcl cream

  • NDC Code(s): 77338-009-04
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 12, 2024

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  • Active ingredients

    Lidocaine HCl 4%

  • Purpose

    Lidocaine HCl - Topical anesthetic

  • Uses

    temporarily relieves minor pain

  • Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • use only as directed
    • do not get into eyes
    • do not bandage tightly or apply external heat (such as a heating pad) to the area of use

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness, rash, or irritation occurs
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center (800-222-1222) right away.

  • Directions

    • adults and children 12 years and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    • children under 12 years: ask a doctor
  • Inactive ingredients

    aloe vera leaf, carbomer 940, ceteth-20, cetostearyl alcohol, dimethicone, glycerin. glyceryl monostearate, isopropyl alcohol, petrolatum, phenoxyethanol, polysorbate 60, trolamine, water

  • Package/Label Principal Display Panel

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PAIN RELIEF 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-009-0476.5 g in 1 TUBE; Type 0: Not a Combination Product03/12/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/12/2024
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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