DIBUCAINE- dibucaine 1% ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)

Available from:

Trifecta Pharmaceuticals USA LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Hemorrhoidal Ointment Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders. - Bleeding occurs - Condition worsens or does not improve within 7 days In or near eyes In children under 2 years of age

Authorization status:

OTC monograph final

Summary of Product characteristics

DIBUCAINE- DIBUCAINE 1% OINTMENT
TRIFECTA PHARMACEUTICALS USA LLC
----------
GLOBE DIBUCAINE OINTMENT 1%
_DRUG FACTS_
_ACTIVE INGREDIENT_
Dibucaine 1%
Hemorrhoidal Ointment
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 20º-25ºC (68º-77ºF)
_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
DIBUCAINE
dibucaine 1% ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69396-023
Trifecta Pharmaceuticals USA LLC
ROUTE OF ADM