DIBUCAINE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

DIBUCAINE

Composition:

DIBUCAINE 1 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Anesthetic Uses: - for temporary relief of pain and itching associated with: - sunburn - minor burns - hemorrhoids - cuts - scratches - insect bites - stings

Authorization status:

OTC monograph final

Summary of Product characteristics

DIBUCAINE- DIBUCAINE OINTMENT
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS 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._
----------
DIBUCAINE OINTMENT USP, 1%
ACTIVE INGREDIENT:
Dibucaine 1%
PURPOS E:
Topical Anesthetic
US ES :
for temporary relief of pain and itching associated with:
sunburn
minor burns
hemorrhoids
cuts
scratches
insect bites
stings
WARNINGS :
For external use only
Do not use in the eyes
Stop use and ask a doctor if
the condition persists or if rash or irritation develops
you have rectal bleeding
KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER
RIGHT AWAY.
DIRECTIONS :
not for prolonged use
adults should not use more than the tube in 24 hours or 1/4 tube for
child
apply to affected area 3 or 4 times daily
cover with light dressing, if necessary
OTHER INFORMATION:
store at room temperature.
see crimp of tube for Lot Number and Expiration Date.
INACTIVE INGREDIENTS
acetone sodium bisulfite 1/2% as a preservative, lanolin, purified
water, white petrolatum
QUESTIONS OR COMMENTS? CALL TOLL FREE 1-800-645-9833
E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, NY 11747
C4905B
R12/11
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
Fougera
NDC 0168-0046-31
CHILD-RESISTANT PACKAGE
DIBUCAINE OINTMENT USP, 1%
TOPICAL ANESTHETIC
NET WT 28.35g (1 Oz)
FOR EXTERNAL USE ONLY
DO NOT USE IN THE EYES
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
NDC 0168-0046-31
Fougera
DIBUCAINE OINTMENT USP, 1%
®
®
TOPICAL ANESTHETIC
NET WT 28.35g (1 Oz)
Laminate Tube with Child-Resistant Cap
FOR EXTERNAL USE ONLY
DO NOT USE IN THE EYES
DIBUCAINE
dibucaine ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 16 8 -0 0 46
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DIBUCAINE (UN