DIBUCAINE- dibucaine 1% ointment

Dibucaine by

Drug Labeling and Warnings

Dibucaine by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC, Trifecta Pharmaceuticals USA LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Dibucaine 1%

PURPOSE

Hemorrhoidal Ointment

INDICATIONS & USAGE

Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders.

If Pregnant or Breast-Feeding

Ask a health care professional before use.

Stop Use and ask a doctor

• Bleeding occurs
• Condition worsens or does not improve within 7 days

Keep out of the reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

In or near eyes

In children under 2 years of age

Warnings

For External use only

Allergy alert

Certain persons can develop allergic reactions to ingredients in this product.

If the symptoms being treated do not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

When using this product

Do not use more than directed unless directed by a doctor

Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Directions

• Adults and children 12 years of age or older. If possible, clean the affected area by platting or blotting with an appropriate cleansing wipe, gently dry by patting or blotting with a tissue or a soft cloth before applying.
• Apply externally to the affected area up to 3 to 4 times daily.

Children under 12 years of age. ask a doctor

Questions or Comments?

Call Toll Free 1-888-296-9067

Other Information

• Store at room temperature 20º-25ºC (68º-77ºF)

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

Made in China

* This product is not manufactured or distributed by Ducere Pharma, Distributor of Nuper-Cainal

Child Resistant Packaging

Packaging

INGREDIENTS AND APPEARANCE

DIBUCAINE 
dibucaine 1% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)	DIBUCAINE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
LANOLIN (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-023-01	1 in 1 BOX	09/14/2022
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/14/2022

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)