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:

Chain Drug Marketing Association Inc.

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
CHAIN DRUG MARKETING ASSOCIATION INC.
_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._
----------
QUALITY CHOICE 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
patting or blotting with appropriate cleansing wipes or with mild soap
and warm water
and rinse thoroughly. 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 1-800-935-2362
_OTHER INFORMATION_
Store at room temperature 20º-25ºC (68º-77ºF)
_INACTIVE INGREDIENTS_
Lanolin, Light Mineral Oil, Purified Water, White Petrolatum
DISTRIBUTED BY
Distributed by: CDMA, Inc.
Novi, MI 48375 USA
1-800-935-2362
* This product is not manufactured or distributed by Ducere Pharma,
Distri