SPL v1
SPL
SPL Set ID a253730a-2187-07de-e053-2a95a90a9877
Route
TOPICAL
Published
Effective Date 2019-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-01

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 tightly 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 redness or irritation develops.

Indications and Usage

Adults and children over 12 years: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but no more than 4 times daily. Children under 12 years or younger: ask a doctor.

Dosage and Administration

Temporarily relieves minor pain associated with arthritis, simple backache, muscle strain, sprains, bruises, cramps.

Description

Trolamine Salicylate 10%

Section 50565-1

Keep out of reach of children.

Section 51727-6

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Blue 1, Copper PCA, Ethyhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Water.

Section 51945-4

Section 53414-9

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 over 12 years: apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but no more than 4 times daily. Children under 12 years or younger: ask a doctor.

Dosage and Administration (34068-7)

Temporarily relieves minor pain associated with arthritis, simple backache, muscle strain, sprains, bruises, 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 tightly 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 redness or irritation develops.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Blue 1, Copper PCA, Ethyhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Water.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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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