DIBUCAINE- dibucaine ointment
GERITREX CORP

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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Dibucaine Ointment

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

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

Label of Tube

DIBUCAINE
dibucaine ointment

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIBUCAINE (DIBUCAINE)	DIBUCAINE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ACETONE SODIUM BISULFITE
LANOLIN
MINERAL OIL
WATER
PETROLATUM

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54162-011-01	28 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/06/2014

Labeler - GERITREX CORP (112796248)

Registrant - GERITREX CORP (112796248)

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

Revised: 1/2014

Document Id: 1e1629af-f686-418c-b9c4-e0f36d76e406

Set id: fc11a231-1d2f-42ba-8ece-34495a14ab44

Version: 1

Effective Time: 20140106

GERITREX CORP