Label: PAIN RELIEVING CREAM LIDOCAINE- benzyl alcohol, lidocaine hci cream

  • NDC Code(s): 69396-139-03
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 22, 2023

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

  • Active Ingredient

    Lidocaine HCL 4%

  • Purpose

    Topical Anasthetic

  • ACTIVE INGREDIENT

    Benzyl Alcohol 10%

  • Purpose

    Topical Anesthetic

  • Uses

    Temporary Pain Relief

  • Do Not Use

    • On wounds or damaged skin
    • In large quantities
    • With a heating pad
    • if you are allergic to any ingredients of this product
  • When Using this Product

    • Use only as direcgted
    • Avoid contact with eyes, mucous membranes or rashes
    • Do not bandage tightly
  • Warnings

    For external Use Only

    Do not use

    • in eyes
    • in large quantities
    • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
    • for more than one week unless directed by a doctor
  • If Pregnant or Breast Feeding

    Ask a health professional before use

  • Keep out of reach of children

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

  • Directions

    Adults and children over 12 years

    • clean and dry affected area
    • Apply to affected area not more than 3 to 4 times daily

    Children 12 years or younger

    • ask a doctor
  • Stop Use and Ask a Doctor If

    • Skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Conditions worsen
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
  • Other Information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
    • Store with lid closed tightly
  • Inactive Ingredients

    Aloe barbadensis leaf juice, aminomethyl propanol, Butylene glycol, carbome interpolymer type A (allyl sucrose crosslinked), Ceteth-10 phosphate, Cetostearyl alcohol, Dihexadecyl phosphate, Dimethicone, Glyceryl 1-stearate, Hydroxyethly acrylate/sodium acryloydimethyl taurate copolymer, maltodextrin, polysorbate 80, SD alcohol, Steareth-21, water

  • Distributed By

    Trifecta Pharmaceuticals USA®

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • Questions

    Call 1-888-296-9067

  • PRINCIPAL DISPLAY PANEL

    4054 GLOBE LIDOCAINE 4 PERCENT PAIN RELIEF CREAM 3OZ REV09 091223 CDER

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING CREAM LIDOCAINE 
    benzyl alcohol, lidocaine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    STEARETH-21 (UNII: 53J3F32P58)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-139-031 in 1 BOX08/23/2023
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/23/2022
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)