DIBUCAINE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

GERITREX LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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
GERITREX LLC
_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
DRUG FACTS
Active ingredient Purpose
Dibucaine 1% Topical Anesthetic
US ES
For temporary relief of pain and itching associated with sunburn,
minor burns, hemorrhoids, cuts,
scratches, insect bites, stings
DIRECTIONS
Not for prolonged use
Adults should not use more than 1oz in 24 hours or 1/4 oz for child
Apply to affected area 3 or 4 times daily
Cover with light dressing, if necessary
WARNINIGS
For External Use Only
Do not get into the eyes. Stop use and ask a doctor if the condition
persists of if rash and irritation
develops. you have rectal bleeding
INACTIVE INGREDIENTS
Aceton Sodium Bisulfate, Lanolin, Mineral Oil, Purified water, White
Petrolatum
KEEP OUT OF REACH OF CHILDREN
In the event of accidental ingestion, contact a Poison Control Center
right away
Store at room temperature 15-30'C (59-86'F)
Apply to affected area 3 or 4 times daily
DIBUCAINE
dibucaine ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:5416 2-0 11
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DIBUCAINE (UNII: L6 JW2TJG9 9 ) (DIBUCAINE - UNII:L6 JW2TJG9 9 )
DIBUCAINE
0 .28 g in 28 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ACETO NE SO DIUM BISULFITE (UNII: 47VY0 54OXY)
LANO LIN (UNII: 7EV6 5EAW6 H)
MINERAL O IL (UNII: T5L8 T28 FGP)
GERITREX LLC
WATER (UNII: 0 59 QF0 KO0 R)
PETRO LATUM (UNII: 4T6 H12BN9 U)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:5416 2-0 11-0 1
28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 7/31/20 15
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt346
0 7/31/20 15
LABELER -
GERIT R