Label: FLORASEPTIC WOUND GEL- benzethonium chloride, allantoin gel

  • NDC Code(s): 52261-0602-1
  • Packager: Cosco International, 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 June 30, 2022

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  • DRUG FACTS

    Active Ingredient/Purpose:

    Benzethonium Chloride (0.12%)..............Antiseptic

    Allantoin (0.5%)...............................Skin Protectant

  • 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 infection

  • Warnings:

    For external use only.

  • Do not use:

    • in the eyes
    • over large areas of the body

  • Ask a doctor before use if you have:

    • deep or puncture wounds
    • deep cuts
    • animal bites
    • serious burns

  • When using this product:

    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • Apply only to the affected area. Avoid ingestion.

  • 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 immediately.

  • Directions:

    Adults and children 2 years of age and older:
    • Clean minor cut, scrapes, or burns by thoroughly flushing the affected area with water or a wound cleanser and let air dry
    • Apply appropriate layer of the gel to cover the affected area
    • Cover with adhesive bandage or sterile gauze if needed
    • Apply 1 to 3 times daily
    • Children under 2 years of age: ask a doctor

  • Inactive Ingredients:

    Aloe Barbadensis Leaf Juice, C13-14 Isoparaffin, Ethanol, Ethylhexylglycerin, Glycerin, Hydrastis Canadensis L., Hydrolyzed Bovine Collagen, Laureth-7, Panax Quinquefolius L., Phenoxyethanol, Sodium Acryloyldimethyltaurate-Acrylamide Copolymer, Sodium Hyaluronate, Sodium Hydroxide, Water

  • Storage and handling:

    Store at room temperature 68°F to 77°F (20° to 25°C)
    Do not expose to excessive heat
    May discolor or stain certain fabrics

  • For Questions:

    +1-(833) 432-5435
    BonePharm, LLC.

    6104 River Terrace
    Tampa, FL  33604

    1 (833) HEALGEL
    WWWBONEPHARM.COM

  • PRINCIPAL DISPLAY PANEL

    3oz tube label

  • INGREDIENTS AND APPEARANCE
    FLORASEPTIC WOUND GEL 
    benzethonium chloride, allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.0012 kg  in 1 kg
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.0050 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PANAX QUINQUEFOLIUS WHOLE (UNII: 0P067WOA1X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-0602-10.0850 kg in 1 TUBE; Type 0: Not a Combination Product07/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2022
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-0602) , label(52261-0602) , pack(52261-0602)
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