MedPath

New Terocin

New Terocin Topical Pain Relief Lotion

Approved
Approval ID

186445d4-ef73-4d34-849d-4661a3eaa43a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Preferred Pharmaceuticals Inc.

DUNS: 791119022

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Methyl Salicylate, Capsaicin, and Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68788-7821
Application Numberpart348
Product Classification
M
Marketing Category
C200263
G
Generic Name
Methyl Salicylate, Capsaicin, and Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (21)

METHYL SALICYLATEActive
Quantity: 25 g in 100 mL
Code: LAV5U5022Y
Classification: ACTIB
CAPSAICINActive
Quantity: 0.025 g in 100 mL
Code: S07O44R1ZM
Classification: ACTIB
MENTHOL, UNSPECIFIED FORMActive
Quantity: 10 g in 100 mL
Code: L7T10EIP3A
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PEG-100 MONOSTEARATEInactive
Code: YD01N1999R
Classification: IACT
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
LIDOCAINEInactive
Code: 98PI200987
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
BORAGE SEED OILInactive
Code: F8XAG1755S
Classification: IACT
INDIAN FRANKINCENSEInactive
Code: 4PW41QCO2M
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
IODOPROPYNYL BUTYLCARBAMATEInactive
Code: 603P14DHEB
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

Package/Label Principal Display Panel

NDC 68788-7821-1

New Terocin

Topical Pain
Relief Lotion

Long Lasting
Soothing Effect

120 ml (4 fl oz.)

Manufactured for: Alexso Inc.
Los Angeles, CA 90064

Store in a dry, cool place

Made in U.S.A.
Patent Pending

For Comments or Questions,
call 888-495-6075

Relabeled By: Preferred Pharmaceuticals Inc.

Terocin Topical Pain Relief Lotion

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/30/2025

Uses:

Temporarily relieves mild aches and pains of muscles or joints.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

Inactive Ingredients:

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/30/2025

Directions:

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.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

Warnings

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 - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

Active ingredients:

Methyl Salicylate 25%
Capsaicin 0.025%
Menthol 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/30/2025

Purpose

Topical Analgesic

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New Terocin - FDA Drug Approval Details