DIBUCAINE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Padagis Israel Pharmaceuticals Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Hemorrhoidal/topical analgesic for hemorrhoidal:

Authorization status:

OTC monograph final

Summary of Product characteristics

DIBUCAINE- DIBUCAINE OINTMENT
PADAGIS ISRAEL PHARMACEUTICALS LTD
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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PERRIGO DIBUCAINE OINTMENT 1% DRUG FACTS
ACTIVE INGREDIENT
Dibucaine 1%
PURPOSE
Hemorrhoidal/topical analgesic
USES
for hemorrhoidal:
•
•
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
•
•
WHEN USING THIS PRODUCT
for hemorrhoidal:
•
•
for the temporary relief of pain, itching and burning due to
hemorrhoids and other
anorectal disorders for topical analgesic:
for the temporary relief of pain and itching caused by sunburn, minor
burns, minor
cuts, scrapes, insect bites or minor skin irritation
in or near the eyes
in infants under 2 years of age or weighing less than 35 pounds
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 applicator
for topical analgesic:
•
STOP USE AND ASK A DOCTOR IF
for hemorrhoidal:
•
•
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:
•
•
•
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
do not use in large quantities, particularly over raw surfaces or
blistered areas
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