FDA.reportPublic FDA data

Bactine ® Max Pain Relieving Cleansing Spray

Manufacturer
WellSpring Pharmaceutical Corporation
Effective date
2021-02-24
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:51:24

Label at a glance#

ProductBactine Max
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor: cuts scrapes minor burns sunburn minor skin irritations

Dosage and administration

adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first) children under 2 years, ask a doctor

Storage and handling

avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
 Benzalkonium Cl 0.13% w/w First aid antiseptic
 Lidocaine HCl 4% w/w Pain relieving spray

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor:

  • cuts
  • scrapes
  • minor burns
  • sunburn
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eyes
  • do not apply over large areas of the body or in large quantities
  • do not apply over raw surfaces or blistered areas

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first)
  • children under 2 years, ask a doctor

Other information

STORAGE AND HANDLING SECTION

avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

edetate disodium, fragrances, propylene glycol, purified water

Questions?

OTC - QUESTIONS SECTION

1-844-241-5454  Mon-Fri (8-5 EST) or www.bactine.com

SPL UNCLASSIFIED SECTION

Money Back Guarantee

Manufactured for: WellSpring, Sarasota, FL 34243

©2018

*germs commonly associated with skin infections.

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Pain Reliever & Antiseptic

Kills 99% of Germs*

Max Strength Germ Killing

4% Lidocaine HCL

Max Strength Pain Reliever

No Sting

 5 FL OZ (148 mL)

Front Bottle Label
Front Bottle Label

DRUG FACTS LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle Label (Back)
Bottle Label (Back)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Pain Reliever & Antiseptic

Kills 99% of Germs*

Max Strength Germ Killing

4% Lidocaine HCL

Max Strength Pain Reliever

No Sting

 4 FL OZ (118 mL)

First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 4 FL OZ (118 mL)First Aid Pain Reliever & Antiseptic Kills 99% of Germs* Max Strength Germ Killing 4% Lidocaine HCL Max Strength Pain Reliever No Sting 4 FL OZ (118 mL)Rear LabelRear Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2047879Bactine MAX 0.13 % / 4 % Topical SprayPSN9
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSN9
2047879benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical Spray [Bactine]SBD9
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD9
2047879Bactine (benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % ) Topical SpraySY9
2047879Bactine (benzalkonium chloride 1.3 MG / lidocaine hydrochloride 40 MG) per ML Topical SpraySY9
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySY9

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-811-14Bactine Max118 mL in 1 BOTTLE, PLASTICLIQUID1189
65197-811-15Bactine Max148 mL in 1 BOTTLELIQUID1489

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65197-811BACTINE MAX (BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE) LIQUID [WELLSPRING PHARMACEUTICAL CORPORATION]9Current NDC, Legacy NDC, 2 package rows20250110_28e8a311-20a4-45a1-8d5d-ca42b101c275.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
65197-81165197-811-15, 65197-811-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
EDETATE DISODIUM7FLD91C86KIACT
NONOXYNOL-948Q180SH9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

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 MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
ndc (package): 65197-811-15
ndc (package): 65197-811-14
ndc (product): 65197-811
ndc11 (package): 65197081115
ndc11 (package): 65197081114
spl id: ec2ae48c-3497-4a66-a88c-4838a37ad3df
spl set id: 28e8a311-20a4-45a1-8d5d-ca42b101c275

Reported adverse events (FAERS/openFDA)#

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