FDA.reportPublic FDA data

New Terocin Lotion

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:23

Label at a glance#

ProductNew Terocin
Active ingredientMENTHOL, METHYL SALICYLATE, CAPSAICIN
Label structure11 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#

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25%
Capsaicin 0.025%
Menthol 10%

OTC - PURPOSE SECTION

Topical Analgesic

Uses

SPL UNCLASSIFIED SECTION

Temporarily relieves mild aches and pains of muscles or joints.

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.

Keep out of reach of children.

Consult physician for children under 12.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Consult physician for children under 12.

Directions

SPL UNCLASSIFIED 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.

DOSAGE & ADMINISTRATION SECTION

As directed

INDICATIONS & USAGE SECTION

Consult your physician

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Borago Officinalis (Borage) Seed Oil, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetyl Alcohol, Diazolidinyl Urea, Dimethyl Sulfone (DMSO), DMDM Hydantoin, Glyceryl Stearate, Lavandula Angustifolia (Lavender) Oil, Methyl Paraben, PEG-100 Stearate, Polysorbate-20, Polysorbate-60, Propyl Paraben, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum.

HOW SUPPLIED SECTION

Bottle of:

120ml NDC: 80425-0256-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 1label 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionPSN2
1372464capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 250 MG/ML Topical LotionSCD2
1372464capsaicin 0.025 % / menthol 10 % / methyl salicylate 25 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0256-1New Terocin120 mL in 1 BOTTLELOTION1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0256NEW TEROCIN (METHYL SALICYLATE, CAPSAICIN, AND MENTHOL) LOTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_f4bfc4a6-06ef-1f76-e053-2995a90a2b8f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0256-1ML - Milliliter80425-0256193c54fd-8c4b-4d35-b5a1-8c8d0337530412023-06-06
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 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80425-025680425-0256-1
50488-1129

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 60CAL22UVI4MIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PROPYLPARABENZ8IX2SC1OHIACT
MENTHOLL7T10EIP3AACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
BORAGE SEED OILF8XAG1755SIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
METHYL SALICYLATELAV5U5022YACTIB
CAPSAICINS07O44R1ZMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
DMDM HYDANTOINBYR0546TOWIACT
LAVENDER OILZBP1YXW0H8IACT

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 MENTHOLAdvanced Rx Pharmacy of Tennessee, LLCf4bfc4a6-06ef-1f76-e053-2995a90a2b8f2024-12-31WarningsExact identifier
ndc (package): 80425-0256-1
ndc (product): 80425-0256
ndc11 (package): 80425025601
spl id: 2a9b9724-0252-e829-e063-6394a90a1c07
spl set id: f4bfc4a6-06ef-1f76-e053-2995a90a2b8f
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
ndc (product): 50488-1129

Reported adverse events (FAERS/openFDA)#

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