Active Ingredient
Dibucaine 1%
Dibucaine Ointment
FDA Label NDC 69396-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Dibucaine (NDC 69396-023). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, otc - purpose, indications & usage, if pregnant or breast-feeding, stop use and ask a doctor, keep out of the reach of children, do not use, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hemorrhoidal Ointment
Indications & Usage
Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders.
If Pregnant Or Breast-Feeding
Ask a health care professional before use.
Stop Use And Ask A Doctor
- Bleeding occurs
- Condition worsens or does not improve within 7 days
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
In or near eyes
In children under 2 years of age
Warnings
For External use only
Allergy alert
Certain persons can develop allergic reactions to ingredients in this product.
If the symptoms being treated do not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.
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.
Directions
- Adults and children 12 years of age or older. If possible, clean the affected area by platting or blotting with an appropriate cleansing wipe, gently dry by patting or blotting with a 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
Questions Or Comments?
Call Toll Free 1-888-296-9067
Other Information
- Store at room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Lanolin, Light Mineral Oil, Purified Water, White Petrolatum
Distributed By
Trifecta Pharmaceuticals USA
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
1-888-296-9067
Made in China
* This product is not manufactured or distributed by Ducere Pharma, Distributor of Nuper-Cainal
Child Resistant Packaging
Packaging
Globe-dibucaine-1oz-cder (Globe Dibucaine 1oz Cder)
* Please review the disclaimer below.
