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.

Active Ingredient

Trolamine Salicylate 10%

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.


Structured Label Content

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.

Active Ingredient (55106-9)

Trolamine Salicylate 10%

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.

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)