Otc - Active Ingredient
Policresulen Solution
The following Structured Product Label (SPL) was submitted to the FDA by Lydia Co., Ltd. for the product Albothyl (NDC 72988-0035). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Policresulen Solution
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
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
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
Water; Sorbitol; Propylene Glycol; Poloxamer
for oral use
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