Active Ingredients (W/W)
Lidocaine HCl 4%
Bactine Max Lidocaine Roll-on 2.5oz Liquid
FDA Label NDC 65197-840
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Bactine Max Lidocaine Roll-on 2.5oz (NDC 65197-840). 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 ingredients (w/w), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, flammable, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Uses
temporarily relieves minor pain
Warnings
For external use only
Do Not Use
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
When Using This Product
- use only as directed. Read and follow all directions and warnings on this carton.
- do not allow contact with the eyes
- do not bandage or apply local heat (such as heating pads) to area of use
Stop Use And Ask A Doctor If
- condition worsens
- symptoms persist for more than 7 days, or clear up and occur again within a few days
Flammable
- keep away from fire or flame
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of Reach Of Children And Pets
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older:
- apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
- children 12 years or younger: ask a doctor
- children under 2 years of age: do not use
Other Information
Store at room temperature
Inactive Ingredients
aloe barbadensis leaf juice, carbomer, disodium EDTA, glycerin, phenylcarbinol, purified water, sodium hydroxide.
Questions?
1-844-241-5454 or Bactine.com
Distributed By:
WellSpring Pharmaceutical Corporation
Sarasota, FL 34243
© 2023 WellSpring Pharmaceutical Corporation
Package Label. Principal Display Panel
NO MESS MAX PAIN RELIEF WITH LIDOCAINE
Numbs Away Pain and Itch
Fast Acting
For Pain, Minor Burns, Bug Bites & Sunburn
Max Strength Lidocaine
No Mess Applicator
Fast Acting
With Aloe Vera
Non-Greasy
Quick Dry Formula
HSA/FSA Eligible
MONEY BACK GUARANTEE
IMPORTANT:
Keep this carton for future reference on full labeling.
* Max Lidocaine HCL concentration per FDA External Analgesic OTC monograph
NDC 65197-840-25
Ct84000a Bactine Max Roll-on Artwork (Bactine Max Lidocaine Roll On 1)
Back Panel
New
Bactine Max
Liquid Bandage with Lidocaine
SHAKE WELL
Bactine Max Liquid Bandageʼs unique formula provides maximum strength pain relief with LIDOCAINE, kills 99.9% of germs*, and protects hard-to-cover minor cuts and scrapes. This flexible bandage dries clear quickly and is breathable to maximize healing.
* Please review the disclaimer below.
