Dibucaine by Akron Pharma Inc. DIBUCAINE ointment

Dibucaine by

Drug Labeling and Warnings

Dibucaine by is a Otc medication manufactured, distributed, or labeled by Akron Pharma Inc.. 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

Sodium Metabisulfite, Lanolin,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

Questions or Comments?

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

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

Manufactured In USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIBUCAINE 
dibucaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-2829
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
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-2829-1	28 g in 1 TUBE; Type 0: Not a Combination Product	09/13/2024
2	NDC: 71399-2829-2	1 in 1 PACKAGE	09/13/2024
2		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	09/13/2024

Labeler - Akron Pharma Inc. (067878881)

Registrant - AKRON FORMULATIONS INDIA PRIVATE LIMITED (862584260)

Establishment
Name	Address	ID/FEI	Business Operations
AKRON FORMULATIONS INDIA PRIVATE LIMITED		862584260	manufacture(71399-2829)