New Terocin — v5

New Terocin

3 Views

Version

v5

Effective date

September 30, 2025

Original packager

—

Sections captured

11

Identifiers

Document ID
805ae929-c59a-46ab-b2da-ea1586dec0e6
Set ID
186445d4-ef73-4d34-849d-4661a3eaa43a
Application numbers
part348
Product NDCs
68788-7821
Package NDCs
68788-7821-1
Original packager NDCs
50488-1129

Names & Manufacturers

Brand names
New Terocin
Generic names
METHYL SALICYLATE, CAPSAICIN, AND MENTHOL
Manufacturer names
Preferred Pharmaceuticals Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
CAPSAICIN, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
L7T10EIP3A, LAV5U5022Y, S07O44R1ZM
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients: Methyl Salicylate 25% Capsaicin 0.025% Menthol 10%
Ask Doctor (1)

Sequence 1

Consult your physician: if pain is persistent or worsens or if using any other topical pain products.
Do Not Use (1)

Sequence 1

Do Not Use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
Dosage And Administration (1)

Sequence 1

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.
Inactive Ingredient (1)

Sequence 1

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.
Indications And Usage (1)

Sequence 1

Uses: Temporarily relieves mild aches and pains of muscles or joints.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. Consult physician for children under 12.
Package Label Principal Display Panel (1)

Sequence 1

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. Label Terocin Topical Pain Relief Lotion
Purpose (1)

Sequence 1

Purpose Topical Analgesic
Spl Product Data Elements (1)

Sequence 1

New Terocin Methyl Salicylate, Capsaicin, and Menthol METHYL SALICYLATE SALICYLIC ACID CAPSAICIN CAPSAICIN MENTHOL, UNSPECIFIED FORM MENTHOL WATER PROPYLENE GLYCOL CETYL ALCOHOL STEARIC ACID GLYCERYL MONOSTEARATE PEG-100 MONOSTEARATE DIMETHYL SULFONE LIDOCAINE LAVENDER OIL ALOE VERA LEAF BORAGE SEED OIL INDIAN FRANKINCENSE XANTHAN GUM TROLAMINE METHYLPARABEN PROPYLPARABEN DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE
Warnings (1)

Sequence 1

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.

OpenFDA raw payload

{'application_number': ['part348'],
 'brand_name': ['New Terocin'],
 'generic_name': ['METHYL SALICYLATE, CAPSAICIN, AND MENTHOL'],
 'manufacturer_name': ['Preferred Pharmaceuticals Inc.'],
 'original_packager_product_ndc': ['50488-1129'],
 'package_ndc': ['68788-7821-1'],
 'product_ndc': ['68788-7821'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['805ae929-c59a-46ab-b2da-ea1586dec0e6'],
 'spl_set_id': ['186445d4-ef73-4d34-849d-4661a3eaa43a'],
 'substance_name': ['CAPSAICIN',
                    'MENTHOL, UNSPECIFIED FORM',
                    'METHYL SALICYLATE'],
 'unii': ['S07O44R1ZM', 'L7T10EIP3A', 'LAV5U5022Y']}