FDA.reportPublic FDA data

Bactine Max Lidocaine Roll-on 2.5oz

Manufacturer
WellSpring Pharmaceutical Corporation
Effective date
2023-04-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:18

Label at a glance#

ProductBactine Max Lidocaine Roll-on 2.5oz
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves minor pain 

Dosage and administration

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

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purpose 

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain 

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days, or clear up and occur again within a few days

Flammable

SPL UNCLASSIFIED SECTION

  • keep away from fire or flame

If pregnant or breast-feeding

SPL UNCLASSIFIED SECTION

ask a health professional before use.

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, carbomer, disodium EDTA, glycerin, phenylcarbinol, purified water, sodium hydroxide.

Questions?

OTC - QUESTIONS SECTION

1-844-241-5454 or Bactine.com

Distributed by:

SPL UNCLASSIFIED SECTION

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243

© 2023 WellSpring Pharmaceutical Corporation

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

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 65197-840-25Bactine Max Roll-on ArtworkBactine Max Roll-on Artwork

Back Panel

SPL UNCLASSIFIED SECTION

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.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN2
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD2
1987647lidocaine hydrochloride 4 % Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-840-25Bactine Max Lidocaine Roll-on 2.5oz1 in 1 BOXLIQUID12
65197-840-25Bactine Max Lidocaine Roll-on 2.5oz71 g in 1 BOTTLE, PLASTICLIQUID712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-840BACTINE MAX LIDOCAINE ROLL-ON 2.5OZ (LIDOCAINE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION]2Current NDC, 2 package rows20250110_09b32a98-9131-451e-87a6-81a1e4ed7ec5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65197-84065197-840-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bactine Max Lidocaine Roll-on 2.5ozLIDOCAINEWellSpring Pharmaceutical Corporation09b32a98-9131-451e-87a6-81a1e4ed7ec52023-04-25WarningsExact identifier
ndc (package): 65197-840-25
ndc (product): 65197-840
ndc11 (package): 65197084025
spl id: 119519c2-454f-4d31-8ece-f98e55db1ffd
spl set id: 09b32a98-9131-451e-87a6-81a1e4ed7ec5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.