Thera Derm Pain Relieving Spray

Manufacturer
Manna Omni International Incorporated
Effective date
2018-02-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:54:37

Label at a glance#

ProductTheraDerm
Active ingredientPEPPERMINT OIL, METHYL SALICYLATE 2-ETHYLBUTYRATE, MENTHOL, CAMPHOR OIL
Label structure9 sections

Label contents#

Full prescribing information#

Warning: For External Use Only.

WARNINGS SECTION

Use only as directed. Avoid contact with eyes or mucus menmbranes. Do not apply to worn, damaged, or very sensitive skin. Test on a small area before use. Do not Use in combination with other external analgesic products. Do not bandage tightly, or cover with any type of wrap, except clothing. If condition worsens , or persists for more than 7 days, discontinue use and consult a physcian.

Keep out of the reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical attention or contact poision control Immediately.

INDICATIONS & USAGE SECTION

DIrections: Spray a small amount onto affected area. Repeat 3-4 times daily.

Dosage:

DOSAGE & ADMINISTRATION SECTION

Spray small amount onto affected area every 6 hours no more than 4 times a day.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Extract, am pelopsis radix extract, bletilla tuber extract, Carthmiflos extract,cimicifugae rhizome extract,echinopsis radix extract, glycerin, glycerrhizae radix extract,kaolin,methyl saliciate, myrrha extract, frankincense extract,Poly Acrylic acid,polysorbate 80,polyvinyl alcohol,propyl glycol,propyl paraben, purified water,rhei rhizome extract,titanium oxide,triethanolamine,glucosamine,and MSM.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Methyl Salcylate, Menthol Natural (From Peppermint oil), and Menthol Crystal Solution.

Purpose:

OTC - PURPOSE SECTION

For the temporary relief of minor arthritis pain, simple back ache, muscle sprains, and muscle strains.

Use:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For the temporary relief of minor muscle pain, simple back aches, muscle strain or sprain.

Theraderm Pain Relieving Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theraderm SprayTheraderm Spray

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16903-169-022020-01-31C16284748780-19d75b9d0-ec83-f424-e053-dadaa90a57ceThera Derm Pain Relieving Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16903-169-02TheraDerm120 mg in 1 BOTTLESPRAY1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16903-169THERADERM (METHYL SALICYLATE 2-ETHYLBUTYRATE) SPRAY [MANNA OMNI INTERNATIONAL INCORPORATED]3Legacy NDC, 1 package rows20180220_4ae05042-9d1b-69aa-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16903-16916903-169-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
65986bc2-c2f1-345e-e053-2991aa0ad0944ae05042-9d1b-69aa-e054-00144ff8d46c2018-02-19WarningsExact identifier
spl id: 65986bc2-c2f1-345e-e053-2991aa0ad094
spl set id: 4ae05042-9d1b-69aa-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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