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  5. Label Information: Dibucaine Topical Anesthetic 1% Hemorrhoidal

FDA Label for Dibucaine Topical Anesthetic 1% Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. ​DRUG FACTS
    2. ​ACTIVE INGREDIENT
    3. ​PURPOSE
    4. ​USE
    5. ​WARNINGS
    6. ALLERGY ALERT
    7. DO NOT USE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING
    11. KEEP OUT OF REACH OF CHILDREN.
    12. ​DIRECTIONS
    13. ​OTHER INFORMATION
    14. OTHER
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE LABELING:

Dibucaine Topical Anesthetic 1% Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Rugby Laboratories Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

​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

Other



Lanolin, Light Mineral Oil, Purified Water, White Petrolatum


Questions Or Comments?



call 1-800-645-2158


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