FDA.reportPublic FDA data

New Terocin Topical Pain Relief Lotion

Manufacturer
medsource pharmaceuticals
Effective date
2018-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:53

Label at a glance#

ProductTerocin
Active ingredientMETHYL SALICYLATE, CAPSAICIN, MENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves mild aches and pains of muscles or joints.

Dosage and administration

Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately afterwards to avoid contact with eyes.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves mild aches and pains of muscles or joints.

Warnings

WARNINGS SECTION

  • Only for external use.
  • Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
  • Consult your physician: if pain is persistent or worsens or if using any other topical pain products.
  • Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Consult physician for children under 12.

Directions

DOSAGE & ADMINISTRATION SECTION

Wash and dry affected area. Shake bottle well before each use and gently rub

over area of pain. Use is not recommended more than four times a day. Wash

hands immediately afterwards to avoid contact with eyes.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate,

Propylene Glycol, Dimethyl Sulfone, Lavandula Angustifolia (Lavendar) Oil,

Lidocaine, Aloe Barbadensis Leaf Extract, Borago Officinalis Seed Oil, Boswellia

Serrata Extract, Xanthan Gum, Triethanolamine, Methylparaben, Propylparaben,

DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionPSN1
1372464capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 250 MG/ML Topical LotionSCD1
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionSY1

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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-748-012025-01-30C16284748780-12cef2736-977e-d83d-e063-dadaa90ab31fNew Terocin Topical Pain Relief Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-748-01Terocin120 mL in 1 BOTTLELOTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-748TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20181221_7d77b913-edad-d441-e053-2991aa0a20ce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1129-1ML - Milliliter50488-112951b71bfc-6b6f-4000-8de7-a606a38d26a212013-04-01

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45865-74845865-748-01
50488-1129

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
LIDOCAINE98PI200987IACT
LAVENDER OILZBP1YXW0H8IACT
ALOE VERA LEAFZY81Z83H0XIACT
BORAGE OILF8XAG1755SIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
XANTHAN GUMTTV12P4NEEIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYL SALICYLATELAV5U5022YACTIB
CAPSAICINS07O44R1ZMACTIB
MENTHOLL7T10EIP3AACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
ndc (product): 50488-1129
7d77bb0b-6552-904d-e053-2a91aa0a55437d77b913-edad-d441-e053-2991aa0a20ce2018-12-20WarningsExact identifier
spl id: 7d77bb0b-6552-904d-e053-2a91aa0a5543
spl set id: 7d77b913-edad-d441-e053-2991aa0a20ce

Reported adverse events (FAERS/openFDA)#

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