New Terocin Lotion

New Terocin Lotion
SPL v2
SPL
SPL Set ID f4bfc4a6-06ef-1f76-e053-2995a90a2b8f
Route
TOPICAL
Published
Effective Date 2023-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Salicylic Acid (25 g) Capsaicin (0.025 g)
Inactive Ingredients
Polysorbate 20 Polysorbate 60 Indian Frankincense Stearyl Alcohol Alkyl (c12-15) Benzoate Propylparaben Cetostearyl Alcohol Diazolidinyl Urea Water Propylene Glycol Glyceryl Monostearate Peg-100 Stearate Borage Seed Oil Dimethyl Sulfone Aloe Vera Leaf Cetyl Alcohol Stearic Acid Xanthan Gum Trolamine Methylparaben Dmdm Hydantoin Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-15

Description

Methyl Salicylate 25% Capsaicin 0.025% Menthol 10%


Medication Information

Warnings and Precautions

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.

Indications and Usage

Consult your physician

Dosage and Administration

As directed

Dosage Forms and Strengths

Bottle of:

120ml NDC: 80425-0256-01

Description

Methyl Salicylate 25% Capsaicin 0.025% Menthol 10%

Uses

Temporarily relieves mild aches and pains of muscles or joints.

Section 50565-1

Consult physician for children under 12.

Section 51727-6

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.

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

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.


Structured Label Content

Uses

Temporarily relieves mild aches and pains of muscles or joints.

Indications and Usage (34067-9)

Consult your physician

Dosage and Administration (34068-7)

As directed

Dosage Forms and Strengths (34069-5)

Bottle of:

120ml NDC: 80425-0256-01

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Consult physician for children under 12.

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Methyl Salicylate 25%

Capsaicin 0.025%

Menthol 10%

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.


Advanced Ingredient Data


Raw Label Data

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