FDA.reportPublic FDA data

Thera Plus Pain Relief Cleansing Spray

Manufacturer
Fourstar Group USA, Inc.
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:38

Label at a glance#

ProductThera Plus Pain Relief Cleansing
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years of age and older: clean the affected area spray a small amount of this product to affected area 1 to 3 times daily may be covered with a sterile bandage, if bandaged, let dry first children under 2 years of age: do not use, ask a doctor before use

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

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

Warnings

WARNINGS SECTION

For external use only.

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
  • do not use longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • deep or puncture wounds
  • animal bites 
  • serious burns

Stop use and ask a doctor if 

OTC - STOP USE SECTION

condition worsens, or symptoms persists for more than 7 days or clear up and then occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:

  • clean the affected area
  • spray a small amount of this product to affected area 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged, let dry first
  • children under 2 years of age: do not use, ask a doctor before use

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 59º - 77º F (15º- 25º C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

disodium EDTA, melaleuca alternifolia (tea tree) oil, octoxynol-9, propylene glycol, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-639-3803

Weekdays 9 AM to 4 PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OuterLabel.jpgOuterLabel.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSN2
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD2
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySY2

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
80684-150-00Thera Plus Pain Relief Cleansing148 mL in 1 BOTTLELIQUID1482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-150THERA PLUS PAIN RELIEF CLEANSING (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) LIQUID [FOURSTAR GROUP USA, INC.]2Current NDC, 1 package rows20250306_513a620e-f69a-488d-8abc-36e2efccdc13.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
80684-15080684-150-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
OCTOXYNOL-97JPC6Y25QSIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
ndc (package): 80684-150-00
ndc (product): 80684-150
ndc11 (package): 80684015000
spl id: 2f86d0c4-2bca-74f7-e063-6394a90a8f0b
spl set id: 513a620e-f69a-488d-8abc-36e2efccdc13

Reported adverse events (FAERS/openFDA)#

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