Label: ALBOTHYL- policresulen solution solution
- 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.
Updated March 19, 2019
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- ACTIVE INGREDIENT
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
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.
For buccal use only.
Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator.
Ask a doctor before use if you have a vaginal discharge, rectal bleeding, diaper rash.
When using this product consult a doctor before exceeding recommended dosage.
Stop use and ask a doctor if condition gets worse, condition persists for more than 7 days, condition clears up and occurs again with within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
policresulen solution solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72689-0040 Route of Administration BUCCAL, VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLICRESULEN (UNII: 6I19M5GB0G) (POLICRESULEN - UNII:6I19M5GB0G) POLICRESULEN 720 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72689-0040-1 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/21/2018 Labeler - OASIS TRADING (689991468) Registrant - OASIS TRADING (689991468) Establishment Name Address ID/FEI Business Operations OASIS TRADING 689991468 manufacture(72689-0040) , relabel(72689-0040)