New Terocin

New Terocin
SPL v16
SPL
SPL Set ID 43e5eb27-5541-4b7b-80de-55a79a4dce55
Route
TOPICAL
Published
Effective Date 2025-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (25 g) Capsaicin (0.025 g) Menthol (10 g)
Inactive Ingredients
Aloe Barbadensis Leaf Juice Water Propylene Glycol Alkyl (c12-15) Benzoate Cetostearyl Alcohol Cetyl Alcohol Diazolidinyl Urea Stearic Acid Glyceryl Monostearate Peg-100 Monostearate Polysorbate 20 Polysorbate 60 Dimethyl Sulfone Lavandula Angustifolia (lavender) Oil Borage Oil Boswellia Serrata Gum Xanthan Gum Trolamine Methylparaben Propylparaben Dmdm Hydantoin Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-13

Description

Methyl Salicylate 25% Capsaicin 0.025% Menthol 10%

Purpose

Topical Analgesic

How Supplied

Product: 50090-1353 NDC: 50090-1353-0 120 mL in a BOTTLE


Medication Information

Purpose

Topical Analgesic

How Supplied

Product: 50090-1353

NDC: 50090-1353-0 120 mL in a BOTTLE

Description

Methyl Salicylate 25% Capsaicin 0.025% Menthol 10%

Uses:

Temporarily relieves mild aches and pains of muscles or joints.

Warnings

Only for external use.

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.

Do Not Use:

on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.

Active Ingredients:

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

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.

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.

Methyl Salicylate, Capsaicin, and Menthol

Structured Label Content

Uses:

Temporarily relieves mild aches and pains of muscles or joints.

Purpose

Topical Analgesic

Warnings

Only for external use.

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.

Do Not Use:

on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.

How Supplied (HOW SUPPLIED)

Product: 50090-1353

NDC: 50090-1353-0 120 mL in a BOTTLE

Active Ingredients: (Active ingredients:)

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

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.

Consult Your Physician: (Consult your physician:)

if pain is persistent or worsens or if using any other topical pain products.

Keep Out of Reach of Children. (Keep out of reach of children.)

Consult physician for children under 12.

Methyl Salicylate, Capsaicin, and Menthol

Advanced Ingredient Data


Raw Label Data

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