Thera Derm Roll On

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 22:54:38

Label at a glance#

ProductThera Derm Roll On
Active ingredientMETHYL SALICYLATE 2-ETHYLBUTYRATE, CAMPHOR (NATURAL), PEPPERMINT OIL, MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)-
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Theraderm Roll onTheraderm Roll on is to be used on sore muscles, for minor aches and pains. If pain persists for more than three days consult your doctor.Apply small amount onto affected area and repeat three (3) to four (4) times daily.

INDICATIONS & USAGE SECTION

For the relief of minor aches and pains, muscles aches or sprains, and minor back or arthritis pain.

Warning: For External Use Only

WARNINGS SECTION

Use only as directed. Avoid contact with the eyes and mucous membranes. Do not apply to wounds, damaged or very sensitive skin. Test on a small area before use. DO not use in combination with other analgesic products.DO not bandage tightly or cover with any type of wrap except clothing. If condition worsens, or persists for more than seven days, discontinue use and consult a physician.

Keep out of the Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed,get medical help or contact Poision Control right away.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol Natural

Methyl Salicilate

Peppermint oil

Menthol Crystal

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe extract, Vitamin E Oil ,Lavender Flos,Angelicae Sinesis Rx, Cauda,Salviae,Miltiorrhiza, Chuanxiong, Paeoniae Rubra, Frakinsense, Mrryha, Carthami Flos, Persicae Sm, Cordalis Rz, Nototerygium, Incisum, and Angelica Pubescentis Rx.

OTC - PURPOSE SECTION

For the relief of minor aches and pains, related to strains and sprains and minor injury.

Theraderm Roll on

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Roll OnLabel Roll On

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
16903-171-042020-01-31C16284748780-19d75b9d0-687a-f424-e053-dadaa90a57ceTheraderm Pain Relieving Roll On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16903-171-04Thera Derm Roll On90 mg in 1 BOTTLELIQUID903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16903-171THERA DERM ROLL ON (METHYL SALICYLATE) LIQUID [MANNA OMNI INTERNATIONAL INCORPORATED]3Legacy NDC, 1 package rows20180220_4eb824a6-66ae-01f8-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16903-17116903-171-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
6598841e-0d39-c3b6-e053-2a91aa0ab4494eb824a6-66ae-01f8-e054-00144ff8d46c2018-02-19WarningsExact identifier
spl id: 6598841e-0d39-c3b6-e053-2a91aa0ab449
spl set id: 4eb824a6-66ae-01f8-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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