Dibucaine by GERITREX LLC DIBUCAINE ointment

Dibucaine by

Drug Labeling and Warnings

Dibucaine by is a Otc medication manufactured, distributed, or labeled by GERITREX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient                        Purpose

Dibucaine 1%                  Topical Anesthetic

Uses

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

KEEP OUT OF REACH OF CHILDREN

In the event of accidental ingestion, contact a Poison Control Center right away

STORAGE AND HANDLING

Store at room temperature 15-30'C (59-86'F)

DOSAGE & ADMINISTRATION

Apply to affected area 3 or 4 times daily

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIBUCAINE 
dibucaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)	DIBUCAINE	0.28 g  in 28 g

Inactive Ingredients
Ingredient Name	Strength
ACETONE SODIUM BISULFITE (UNII: 47VY054OXY)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-011-01	28 g in 1 TUBE; Type 0: Not a Combination Product	07/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/31/2015

Labeler - GERITREX LLC (112796248)

Registrant - GERITREX LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
GERITREX LLC		112796248	manufacture(54162-011)