DIBUCAINE- dibucaine ointment 
Akron Pharma 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.

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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

Sodium Metabisulfite, Lanolin,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

Questions or Comments?

Call (877) 225-6999 Monday - Friday 9AM-5PM EST

Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004

Manufactured In USA

1oz

2oz

DIBUCAINE 
dibucaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-2829
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE0.28 g  in 28 g
Inactive Ingredients
Ingredient NameStrength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
LANOLIN (UNII: 7EV65EAW6H)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-2829-128 g in 1 TUBE; Type 0: Not a Combination Product11/04/2021
2NDC:71399-2829-21 in 1 PACKAGE11/04/2021
256 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/04/2021
Labeler - Akron Pharma Inc. (067878881)
Registrant - SLV PHARMACEUTICALS LLC (081225162)
Establishment
NameAddressID/FEIBusiness Operations
SLV PHARMACEUTICALS LLC081225162manufacture(71399-2829)

Revised: 2/2023
Document Id: 56fb50bc-3266-49be-b3b4-6019d7ecfe26
Set id: 60469e43-ab6f-46d3-a1df-00e58275f565
Version: 4
Effective Time: 20230225
 
Akron Pharma Inc.