Tc Pain Relief Cream

Tc Pain Relief Cream
SPL v3
SPL
SPL Set ID ca011b03-a263-1908-e053-2995a90ad970
Route
TOPICAL
Published
Effective Date 2021-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Trolamine Mineral Oil Chamomile Green Tea Leaf Cucumber Propylparaben Calendula Officinalis Flower Water Potassium Phosphate, Monobasic Stearic Acid Glycerin Aloe Vera Leaf Echinacea Angustifolia Leaf Ilex Paraguariensis Leaf Cetyl Alcohol Arnica Montana Flower Juniper Berry Peppermint Oil Methylparaben Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-19

Description

Trolamine Salicylate 10%


Medication Information

Warnings and Precautions

For external use only. Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. . When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

Dosage and Administration

Adults and children 12 years of age and older: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat if necessary but not more than 4 times daily. Children under 12 years of age: ask a doctor.

Description

Trolamine Salicylate 10%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Mentha Piperita (Peppermint) Oil, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding ask a health professional.

Section 55105-1



Topical Analgesic

Section 55106-9

Trolamine Salicylate 10%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

Dosage and Administration (34068-7)

Adults and children 12 years of age and older: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat if necessary but not more than 4 times daily. Children under 12 years of age: ask a doctor.

Warnings and Precautions (34071-1)

For external use only. Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. . When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Mentha Piperita (Peppermint) Oil, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding ask a health professional.

Section 55105-1 (55105-1)



Topical Analgesic

Section 55106-9 (55106-9)

Trolamine Salicylate 10%


Advanced Ingredient Data


Raw Label Data

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