Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment

Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment
SPL v6
SPL
SPL Set ID f23c8cd1-98f9-41cd-84d4-cf01c2ede29a
Route
TOPICAL
Published
Effective Date 2019-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dibucaine (10 mg)
Inactive Ingredients
Lanolin Light Mineral Oil Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-19

Description

Dibucaine 1%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Dibucaine 1%

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

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Do Not Use
  • in or near the eyes
  • in children under 2 years of age
​purpose

Local Anesthetic

​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.
​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 blotting 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
​drug Facts

Package Labeling:

​active Ingredient

Dibucaine 1%

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

call 1-800-639-3803

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 within 7 days
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 (1-800-222-1222) right away.


Structured Label Content

​use (​Use)
  • temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders
Undefined (undefined)

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Do Not Use (Do not use)
  • in or near the eyes
  • in children under 2 years of age
​purpose (​Purpose)

Local Anesthetic

​warnings (​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.
​directions (​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 blotting 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
​drug Facts (​Drug Facts)

Package Labeling:

​active Ingredient (​Active ingredient)

Dibucaine 1%

​other Information (​Other information)
  • Store at 20 o-25 o ​C (68 o-77 o ​F)
  • tamper-evident: do not use if foil seal is broken or missing
Questions Or Comments? (Questions or comments?)

call 1-800-639-3803

When Using This Product (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 (Stop use and ask a doctor if)
  • bleeding occurs
  • condition worsens or does not improve within 7 days
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health care professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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