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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals 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.
Active Ingredient:
Dibucaine 1%
Purpose:
Topical Anesthetic
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
acetone sodium bisulfite 1/2% as a preservative, lanolin, purified water, white petrolatum
Package Label – Principal Display Panel – Container
Fougera®
NDC 0168-0046-31
CHILD-RESISTANT PACKAGE
DIBUCAINE OINTMENT USP, 1%
TOPICAL ANESTHETIC
NET WT 28.35g (1 Oz)
FOR EXTERNAL USE ONLY
DO NOT USE IN THE EYES
Package Label – Principal Display Panel – Carton
NDC 0168-0046-31
Fougera®
DIBUCAINE OINTMENT USP, 1%
TOPICAL ANESTHETIC
NET WT 28.35g (1 Oz)
Laminate Tube with Child-Resistant Cap
FOR EXTERNAL USE ONLY
DO NOT USE IN THE EYES
* Please review the disclaimer below.