Label: ALBOTHYL- policresulen solution liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 10, 2023

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

  • ACTIVE INGREDIENT

    Policresulen Solution

  • PURPOSE

    Oral debriding agent/oral wound cleanser for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums such as mouth burns, cheek bites and toothbrush abrasions. Cleans minor mouth wounds by removing foreign materials that can impede the healing process

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Adults and children 2 years of age and older: rinse half of a capful around in the mouth over affected area for at least 1 minute, then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician. Children under 12 years of age should be supervised in the use of the product. Children under 2 years of age: consult a dentist or physician. To open child safety cap, squeeze smooth sides while turning. Reclose tightly

  • WARNINGS

    Do not use this product for more than 7 days unless directed by a dentist or physician.

    When using this product, do not swallow.

    Stop use and ask a doctor if. Sore mouth symptoms do not improve within 7 days. Irritation, pain or redness persists or worsens. Swelling, rash or fever develops.

    Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Do not use if carton is opened. Do not use if printed band on bottle is broken or missing

  • INACTIVE INGREDIENT

    Water; Sorbitol; Propylene Glycol; Poloxamer

  • DOSAGE & ADMINISTRATION

    for oral use

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALBOTHYL 
    policresulen solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0035
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLICRESULEN (UNII: 6I19M5GB0G) (POLICRESULEN - UNII:6I19M5GB0G) POLICRESULEN720 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72988-0035-15 g in 1 BOTTLE; Type 0: Not a Combination Product01/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/23/2023
    Labeler - Lydia Co., Ltd. (695735569)
    Registrant - Lydia Co., Ltd. (695735569)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lydia Co., Ltd.695735569manufacture(72988-0035)