ALBOTHYL- policresulen solution solution 
OASIS TRADING

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.

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Policresulen

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.

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.

Water

For buccal use only

1

ALBOTHYL 
policresulen solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0040
Route of AdministrationBUCCAL, VAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLICRESULEN (UNII: 6I19M5GB0G) (POLICRESULEN - UNII:6I19M5GB0G) POLICRESULEN720 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0040-15 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/21/2018
Labeler - OASIS TRADING (689991468)
Registrant - OASIS TRADING (689991468)
Establishment
NameAddressID/FEIBusiness Operations
OASIS TRADING689991468manufacture(72689-0040) , relabel(72689-0040)

Revised: 3/2019
Document Id: 847dd36e-0865-6ce1-e053-2a91aa0a82cf
Set id: 847dca04-cfe6-19be-e053-2991aa0a04df
Version: 1
Effective Time: 20190319
 
OASIS TRADING