Dibucaine Ointment

Dibucaine Ointment
SPL v6
SPL
SPL Set ID 60469e43-ab6f-46d3-a1df-00e58275f565
Route
TOPICAL
Published
Effective Date 2025-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dibucaine (0.28 g)
Inactive Ingredients
Lanolin Light Mineral Oil Water White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-06

Description

Active ingredient                        Purpose Dibucaine 1%                  Hemorrhoidal ointment


Medication Information

Description

Active ingredient                        Purpose Dibucaine 1%                  Hemorrhoidal ointment

Uses

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

Section 44425-7

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

Section 51945-4

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.
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
Do Not Use
  • in children under 2 years at age
  • in or near the eyes
Drug Facts

Active ingredient                        Purpose

Dibucaine 1%                  Hemorrhoidal ointment

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified water, White Petrotalum

Questions Or Comments?

call toll-free 1(877)225-6999

Manufactured for

Akron Pharma, Inc.,

Fairfeld, NJ - 07004

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

Structured Label Content

Uses

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

Section 44425-7 (44425-7)

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

Section 51945-4 (51945-4)

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.
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
Do Not Use (Do not use)
  • in children under 2 years at age
  • in or near the eyes
Drug Facts

Active ingredient                        Purpose

Dibucaine 1%                  Hemorrhoidal ointment

Inactive Ingredients

Lanolin, Light Mineral Oil, Purified water, White Petrotalum

Questions Or Comments? (Questions or Comments?)

call toll-free 1(877)225-6999

Manufactured for

Akron Pharma, Inc.,

Fairfeld, NJ - 07004

When Using This Product (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

Advanced Ingredient Data


Raw Label Data

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