DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL- dibucaine ointment

Dibucaine Topical Anesthetic 1% Hemorrhoidal by

Drug Labeling and Warnings

Dibucaine Topical Anesthetic 1% Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Drug Facts

​Active ingredient

Dibucaine 1%

​Purpose

Hemmorhoidal ointment

​Use

• temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders

​Warnings

​For external use only.

Allergy Alert

• Certain persons can develop allergic reactions to ingredients in this product.  If the symptoms being treated does not subside or if redness, irritaion, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

Do not use

• in or near the eyes
• in children under 2 years of age

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 if

• bleeding occurs
• condition worsens or does not improve

If pregnant or breast-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 right away.

​Directions

• adults and children 12 years and over:  If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or with toilet 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

​Other information

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

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Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Questions or comments?

call 1-800-645-2158

Package Labeling:

INGREDIENTS AND APPEARANCE

DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL 
dibucaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)	DIBUCAINE	10 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1211-95	1 in 1 BOX	08/19/2019
1		28 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 final	part346	08/19/2019

Labeler - Rugby Laboratories Inc. (079246066)