ORAMEDY- triamcinolone acetonide ointment

ORAMEDY by

Drug Labeling and Warnings

ORAMEDY by is a Otc medication manufactured, distributed, or labeled by OASIS TRADING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Triamcinolone Acetonide

PURPOSE

For the treatment of chronic exfoliative gingivitis, obstinate stomatitis and glossitis with erosive and ulcerative lesions. For adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Apply a small dab to the lesion once to several times a day.

WARNINGS

For external 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

Sodium Carboxymethyl Cellulose, Sodium Polyacrylate, Pectin, Plastibase

DOSAGE & ADMINISTRATION

For buccal use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAMEDY 
triamcinolone acetonide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72689-0039
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)	TRIAMCINOLONE ACETONIDE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
PECTIN (UNII: 89NA02M4RX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72689-0039-1	10 g in 1 TUBE; 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(72689-0039) , relabel(72689-0039)