Dch Arthritis Relief, 10% Trolamine Salicylate

Dch Arthritis Relief, 10% Trolamine Salicylate
SPL v2
SPL
SPL Set ID ff31e515-5780-b77d-e053-6394a90af6b9
Route
TOPICAL
Published
Effective Date 2021-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Stearic Acid Cetyl Alcohol Water Glycerin Trolamine Methylparaben Mineral Oil Potassium Phosphate, Monobasic Propylparaben Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-20

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, avoid taking a bath or shower within 1 hour before or after applying, do not bandage or use with a heating pad, avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days, if symptoms clear up and occur again within a few days, or if irritation develops.

Indications and Usage

Adults and children 12 years of age: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Dosage and Administration

Temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, and cramps.

Description

Trolamine Salicylate 10%

Section 50565-1

Keep out of reach of children.

Section 51727-6

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health care professional before use.

Section 55105-1

Topical Analgesic.

Section 55106-9

Trolamine Salicylate 10%


Structured Label Content

Indications and Usage (34067-9)

Adults and children 12 years of age: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Dosage and Administration (34068-7)

Temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, and cramps.

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, avoid taking a bath or shower within 1 hour before or after applying, do not bandage or use with a heating pad, avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days, if symptoms clear up and occur again within a few days, or if irritation develops.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, 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 care professional before use.

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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