FDA.reportPublic FDA data

Therapain Plus Spray NDC 67285-102

Manufacturer
Relief-Mart, Inc | Generitech Corporation
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:45

Label at a glance#

ProductMenthol
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Relieves temporary pain due to arthiritus neck and back pains stiffness msucle soreness cramps sprains and strains tendonitis

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only. If accidentally ingested contact poison control immediately.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Natural L-Menthol 2%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Inactive Ingedients

INACTIVE INGREDIENT SECTION

Deionized Water, Isopropyl Alcohol, Oil of Peppermint, Oil of Eucalyptus, Proprietary Skin Conditioner.

Directions

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

Stop use section

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Excessive skin irritation develops
  • Conditions worsens
  • Symptoms persist more than 7 days, discontinue use of this product and consult a doctor

Uses

INDICATIONS & USAGE SECTION

Relieves temporary pain due to

arthiritus

neck and back pains

stiffness

msucle soreness

cramps

sprains and strains

tendonitis

RECENT MAJOR CHANGES SECTION

Uploaded revised label and updated the following information:

  • Dosage and Administration (Directions)
  • Added information on Stop Use and Ask a Doctor if

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label ProofLabel Proof

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67285-102-042022-07-29C16284748780-1e4f33bdf-aa25-d8a0-e053-dadaa90a6e4eTherapain Plus Spray NDC 67285-102

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67285-102-04Menthol118 mL in 1 BOTTLE, SPRAYSPRAY1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67285-102MENTHOL (THERAPAIN PLUS SPRAY) SPRAY [RELIEF-MART, INC]3Legacy NDC, 1 package rows20220114_a5f39258-0385-5217-e053-2a95a90a6290.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67285-10267285-102-04

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
ISOPROPYL ALCOHOLND2M416302IACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOLL7T10EIP3AACTIB
GLUCOSAMINE SULFATE1FW7WLR731IACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
d57e1850-b31c-218f-e053-2995a90ab7eba5f39258-0385-5217-e053-2a95a90a62902022-01-13WarningsExact identifier
spl id: d57e1850-b31c-218f-e053-2995a90ab7eb
spl set id: a5f39258-0385-5217-e053-2a95a90a6290

Reported adverse events (FAERS/openFDA)#

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