Dibucaine by Akron Pharma Inc. DIBUCAINE ointment

Dibucaine by

Drug Labeling and Warnings

Dibucaine by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient                        Purpose

Dibucaine 1%                  Hemorrhoidal ointment

Uses

temporanly relieves pain and nching due to hemorrhoids or other anorectal disorders

Warninigs

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 redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

Do not use

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

When using this product

• avoid contact wnh eyes
• 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

lf 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.

Stop use and ask a doctor if

• bleeding occurs
• condition worsens or does not improve wnhin 7 days

Directions

• adults and children 12 years and over: if possible, clean the affected area with mild soap and wann water and nnse thoroughly. Dry by patting or blotting withh toilet tissue or a soft cloth before applying.
• apply externally to the affected area up to 3 or 4 times daily
• children under 12 years of age: ask a doctor

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified water, White Petrotalum

STORAGE AND HANDLING

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

Questions or Comments?

call toll-free 1(877)225-6999

Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIBUCAINE 
dibucaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-2829
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)	DIBUCAINE	0.28 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WATER (UNII: 059QF0KO0R)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-2829-1	28 g in 1 TUBE; Type 0: Not a Combination Product	01/06/2025
2	NDC: 71399-2829-2	1 in 1 PACKAGE	01/06/2025
2		56 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	M015	01/06/2025

Labeler - Akron Pharma Inc. (067878881)