Label: FORTICEPT WOUNDS AND BURNS HYDROGEL- benzethonium chloride, lidocaine hydrochloride gel

  • NDC Code(s): 72127-0803-0, 72127-0803-1
  • Packager: Lidan, inc.
  • 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 December 29, 2022

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  • DRUG FACTS

    Active Ingredient/Purpose:

    LIDOCAINE HCL (4.0%)..........................Topical Analgesic
    BENZETHONIUM CHLORIDE (0.1%)....................Antiseptic

  • Uses:

    For temporary relief of pain or discomfort for superficial and full thickness burns or wounds. Topical antiseptic to help decrease the risk of infections. Helps protect skin and supports healing of cuts, scrapes, burns, and wounds.

  • INDICATIONS & USAGE

    Topical analgesic - for temporary relief of pain or discomfort for superficial and full thickness burns or wounds.

    Topical antiseptic - to help decrease the risk of wounf and skin infections.

  • WARNINGS:

    For external use only!

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immidiately.

  • WHEN USING

    When using this product avoid contact with eyes.

  • DO NOT USE

    Do not use on children under 2 years of age unless directed by a doctor.

  • STOP USE

    Discontinue Use after 7 days unless directed by a doctor

  • Directions:

    Adults and children 2 years of age and older:
    • Clean affected area from dirt and debris, let it dry.
    • Apply Forticept Analgesic Antiseptic Hydrogel and cover affected area with a clean gauze if needed.
    • Repeat this procedure 1-3 times daily or as needed until condition improves or medical assistance is rendered.

  • ASK DOCTOR

    For children under 2 years of age: please, consult a doctor

  • Inactive Ingredients:

    ALLANTOIN, ALPHA TOCOPHEROL, C13-14 ISOPARAFFIN, CETOSTEARYL ALCOHOL, CHLORPHENESIN, D-PANTHENOL, FD&C BLUE #1, GLYCERIN, HYDROLYZED COLLAGEN, LANOLIN, LAURETH-7, PARAFFINUM LIQUIDUM, PETROLATUM, POLYACRYLAMIDE, POLYHEXANIDE, SHEA BUTTER, STEARETH-2, STEARETH-21, THYMOL, WATER

  • Storage and handling:

    • Keep container closed when not in use.
    • Store at room temperature, avoid freezing.
    • Do not store below 32F/00C or above 95F/350C for extended periods of time.
  • For Questions:

    Lidan, Inc.
    30 Wall Street, 8th Floor
    New York, NY 10005
    www.forticept.com

    Please call: +1 212 709-8133

  • PRINCIPAL DISPLAY PANEL

    3oz label

  • PRINCIPAL DISPLAY PANEL

    4oz label

  • INGREDIENTS AND APPEARANCE
    FORTICEPT WOUNDS AND BURNS HYDROGEL 
    benzethonium chloride, lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72127-0803
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.001 kg  in 1 kg
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72127-0803-00.114 kg in 1 TUBE; Type 0: Not a Combination Product05/06/2020
    2NDC:72127-0803-10.085 kg in 1 TUBE; Type 0: Not a Combination Product02/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/06/2020
    Labeler - Lidan, inc. (014456716)
    Registrant - Lidan, inc. (014456716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(72127-0803) , api manufacture(72127-0803) , label(72127-0803) , pack(72127-0803)
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