FDA.reportPublic FDA data

NEW TEROCIN

Manufacturer
DIRECT RX
Effective date
2023-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:40:35

Label at a glance#

ProductNEW TEROCIN
Active ingredientMETHYL SALICYLATE, CAPSAICIN, MENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

OTC - PURPOSE SECTION

Topical Analgesic

OTC - WHEN USING 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.
Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Consult physician for children under 12.

DESCRIPTION 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 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

578578

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-578-04ML - Milliliter61919-5785eb9abb1-c0c5-461f-a195-02d89be72d6112018-09-05
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
61919-57861919-578-04
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
METHYL SALICYLATELAV5U5022YACTIB
CAPSAICINS07O44R1ZMACTIB
TROLAMINE9O3K93S3TKIACT
MENTHOLL7T10EIP3AACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LAVENDER OILZBP1YXW0H8IACT
ALOE VERA LEAFZY81Z83H0XIACT
BORAGE OILF8XAG1755SIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
LIDOCAINE98PI200987IACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
XANTHAN GUMTTV12P4NEEIACT
PROPYLPARABENZ8IX2SC1OHIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT

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
074cdf12-694f-c161-e063-6294a90a712b746a90fa-8733-6dfb-e053-2a91aa0a147f2023-10-09WarningsExact identifier
spl set id: 746a90fa-8733-6dfb-e053-2a91aa0a147f
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.