Thera Derm Pain Relieving Lotion

Manufacturer
Manna Omni International Incorporated
Effective date
2018-02-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:38

Label at a glance#

ProductThera Derm
Active ingredientCAMPHOR LEAF OIL, 7-AMINODESACETOXYCEPHALOSPORANIC ACID, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE 2-ETHYLBUTYRATE, PEPPERMINT OIL
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains, arthritis pain, backache,muscle vstrains and sprains. Make sure to clean the affected area then apply lotion and rub into the skin until it absorbs.

Dosage and administration

For the temporary relief of minor arthritis pain, simple backache, muscle strains and sprains. Clean affected Area and rub or massage area continuously until lotion has been absoprbed into the area.

Label contents#

Full prescribing information#

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Clean affected Area and rub or massage area continuously until lotion has been absoprbed into the area.

INSTRUCTIONS FOR USE SECTION

Directions: clean the affected area, then apply to pain area. Rub or massage the area continuously until the lotion has been fully absorbed into the area.

Warning: for external use only

WARNINGS SECTION

Use only as directed. Avoid contact with the eyes and mucous membranes. DO not apply to open wounds, 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 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 Poison Control right away.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol, Methyl Salicylate, Peppermint Oil, Camphor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Salvia Miltiorrhiza root, Carthamus Tinctorius Flower Oil, Lavender Oil, Angelica Actiloba Flowering Top, Aloe,Zingiber Cassumunar Root Oil,Angelicae Pubescens Root,Stearic Acid, Prunus Persica Flower Bud,Notopterygium Franchetii Root,Frankincense Oil, Ligusticum Sinese Subsc, Chuanxiong Root, Myrrh,nGlycerin, Vitamin E Oil,Coconut Oil.

Purpose

OTC - PURPOSE SECTION

The Purpose of our pain relieving Lotion is to provide temporary relief of minor aches and pains, arthritiis pain, backache, muscle aches and strains.

Indications and Usage

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains, arthritis pain, backache,muscle vstrains and sprains. Make sure to clean the affected area then apply lotion and rub into the skin until it absorbs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Thera Derm LotionThera Derm Lotion

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
16903-170-032020-01-31C16284748780-19d75b9d0-94f6-f424-e053-dadaa90a57ceThera Derm Pain Relieving Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16903-170-03Thera Derm240 mg in 1 BOTTLELOTION2402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16903-170THERA DERM (METHYL SALICYLATE) LOTION [MANNA OMNI INTERNATIONAL INCORPORATED]2Legacy NDC, 1 package rows20180220_5a5a8ce6-2c7b-e078-e053-2991aa0a0e3a.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16903-17016903-170-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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-c2e7-345e-e053-2991aa0ad0945a5a8ce6-2c7b-e078-e053-2991aa0a0e3a2018-02-19WarningsExact identifier
spl id: 65986bc2-c2e7-345e-e053-2991aa0ad094
spl set id: 5a5a8ce6-2c7b-e078-e053-2991aa0a0e3a

Reported adverse events (FAERS/openFDA)#

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