FDA Label for Dibucaine

View Indications, Usage & Precautions

Dibucaine Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

NDC: 71399-2829-1

Size: 28 G


Otc - 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


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