Label: FORTICEPT ANTIMICROBIAL HYDROGEL WOUND DRESSING- benzethonium chloride, thymol 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 February 20, 2022

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

View All Sections
  • Active Ingredient/Purpose

    Benzethonium Chloride - 0.1%............Antiseptic

    Thymol - 0.1%..................................Antiseptic

    Uses

    Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips. Topical antiseptic to help decrease the risk of skin infections.

  • WARNINGS

    Warnings For external use only.

  • INDICATIONS & USAGE

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

    When using this product avoid contact with eyes.

  • STOP USE

    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

  • 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

  • Directions:

    Adults and children 2 years of age and older:

    Clean affected area from dirt and debris, let it dry. Apply a thin layer of Forticept Antimicrobial Gel and cover affected area with a clean bandage if needed. Repeat this procedure 1-3 times daily or as needed until condition improves.

    Children under 2 years of age: please, consult a doctor

  • Storage and handling:

    Store at room temperature, avoid freezing

  • Inactive ingredients:

    Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Allantoin, Alpha Tocopherol, Cetostearyl Alcohol, Panthenol, Glycerin, Hydrolyzed Collagen, Isohexadecane, Lanolin, Mineral Oil, Petrolatum, Polihexanide, Polysorbate 80, Shea Butter, Steareth-2, Steareth-21, Water

  • 85g Tube

    85g Tube

  • INGREDIENTS AND APPEARANCE
    FORTICEPT ANTIMICROBIAL HYDROGEL WOUND DRESSING 
    benzethonium chloride, thymol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72127-0901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzethonium chloride (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) benzethonium chloride1 g  in 1000 g
    thymol (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) thymol1 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72127-0901-185 g in 1 TUBE; Type 0: Not a Combination Product02/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/20/2022
    Labeler - Lidan, Inc (014456716)
    Registrant - Lidan, Inc (014456716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(72127-0901) , label(72127-0901) , pack(72127-0901) , api manufacture(72127-0901)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!