DIBUCAINE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99)

Available from:

Akron Pharma Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For temporary relief of pain and itching associated with sunburn, minor burns, hemorrhoids, cuts, scratches, insect bites, stings

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
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 [phone] MONDAY - FRIDAY 9AM-5PM EST
MANUFACTURED FOR
AKRON PHARMA, INC.,
Fairfeld, NJ - 07004
Manufactured In USA
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
Akron Pharma Inc.
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
11/04/2021
2
NDC:71399-
2829-2
1 in 1 PACKAGE
11/04/2021
2
56 g in 1 TUBE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR M