DIBUCAINE by NUGERI LLC / UNIPack DIBUCAINE 1% Ointment

DIBUCAINE by

Drug Labeling and Warnings

DIBUCAINE by is a Otc medication manufactured, distributed, or labeled by NUGERI LLC, UNIPack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIBUCAINE- dibucaine ointment 
NUGERI LLC

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DIBUCAINE 1% Ointment

Product Image

Active Ingredient

Dibucaine 1%

Purpose

Hemmorrhoidal ointment

Use

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

Warnings

For external use only

Allery Alert

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, bleeding, orother symptoms develp 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

Stop Use And Ask A Doctor

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

If Pregnant Or Breat-feeding

Ask a health care professional before use.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.

Directons

• Adults and children 12 years and older; if possible clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toliet tissue or 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

Other Information

• Store at 20-25 0 C (68-77 0 F)
• Tamper-evident: do not use if foil seal is broken or missing

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Dibuacine 1% Local Anesthetic

Hemorrhoidal Ointment

For Fast, temporary relief of hemorrhodial pain, itching, and burning

Compare to the active ingredients in Nupercainal ointment

Contains

NET WT. 1 Oz. (28g)

Manufactured And Distributed By

Manufactured By:

Unipack, Inc.

Pittsburgh, PA 15239

info@unipackinc.com

1-724-733-7381

Distributed By

Nugeri, LLC

Tarrytown, NY 10591

info@nurgerirx.com

DIBUCAINE 
dibucaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81266-920
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)	DIBUCAINE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)	0.005 g  in 1 g
LIGHT MINERAL OIL (UNII: N6K5787QVP)	0.02 g  in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4)	0.95 g  in 1 g
WATER (UNII: 059QF0KO0R)	0.0022 mL  in 1 g

Product Characteristics
Color	gray	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81266-920-01	28 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	05/01/2021	10/24/2023

Labeler - NUGERI LLC (117724142)

Registrant - UNIPack (009248480)

Revised: 10/2023

Document Id: 0874bae1-eb7b-3c08-e063-6294a90aaba0

34390-5

Set id: b6ca4519-6c8e-49e0-e053-2995a90af800

Version: 3

Effective Time: 20231024

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