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Dibucaine by GERITREX LLC

Dosage form: ointment
Ingredients: DIBUCAINE 0.28g in 28g
Labeler: GERITREX LLC
NDC Code: 54162-011

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

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

DIBUCAINE 
dibucaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIBUCAINE (DIBUCAINE) DIBUCAINE0.28 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
ACETONE SODIUM BISULFITE 
LANOLIN 
MINERAL OIL 
WATER 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:54162-011-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/31/2015
Labeler - GERITREX LLC (112796248)
Registrant - GERITREX LLC (112796248)
Establishment
NameAddressID/FEIOperations
GERITREX LLC112796248manufacture(54162-011)

Revised: 08/2017
 
GERITREX LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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