Active Ingredient:
Dibucaine 1%
Dibucaine
FDA Label NDC 0168-0046
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. for the product Dibucaine (NDC 0168-0046). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient:, purpose:, keep out of reach of children., inactive ingredients, package label – principal display panel – container, package label – principal display panel – carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 – Label (Dibucaine 01)
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
Package Label – Principal Display Panel – Carton (Dibucaine 02)
* Please review the disclaimer below.
