FDA Label for Dibucaine
View Indications, Usage & Precautions
Dibucaine Product Label
The following document was submitted to the FDA by the labeler of this product Padagis Israel Pharmaceuticals Ltd. 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.
Active Ingredient
Dibucaine 1%
Purpose
Hemorrhoidal/topical analgesic
Uses
for hemorrhoidal:
• for the temporary relief of pain, itching and burning due to hemorrhoids and other anorectal disordersfor topical analgesic:• for the temporary relief of pain and itching caused by sunburn, minor burns, minor cuts, scrapes, insect bites or minor skin irritation
Warnings
For external use only
Allergy warning: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and ask a doctor.
Do Not Use
• in or near the eyes• in infants under 2 years of age or weighing less than 35 pounds
When Using This Product
for hemorrhoidal:
• do not exceed the recommended daily dosage unless directed by a doctor• do not put this product into the rectum by using fingers or any mechanical device or applicatorfor topical analgesic:
• do not use in large quantities, particularly over raw surfaces or blistered areas
Stop Use And Ask A Doctor If
for hemorrhoidal:
• condition worsens or does not improve within 7 days• bleeding occurs• condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
for topical analgesic:
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
for hemorrhoidal:
• adults and children 12 years & older: when practical, clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with 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• adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily• children under 2 years of age: ask a doctor
for topical analgesic:
Other Information
store at 20°-25°C (68°-77°F)
Inactive Ingredients
acetone sodium bisulfite, lanolin, white petrolatum
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Child Resistant Packaging
Temporary Relief of Local Discomfort, Burning and Itching Associated with Inflamed Hemorrhoidal Tissues
Compare to Nupercainal® active ingredient
Dibucaine Ointment 1%
Hemorrhoidal & Topical Analgesic
NET WT 1 OZ (28 g)
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