SPL v3
SPL
SPL Set ID f119a1bd-095f-41f5-86d5-c0ee4f19fd2c
Route
TOPICAL
Published
Effective Date 2024-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (250 mg)
Inactive Ingredients
Water Arnica Montana Flower Indian Frankincense Cetearyl Olivate Cetyl Alcohol Dimethyl Sulfone Ethylhexylglycerin Glycerin Glyceryl Monostearate Hemp Peg-100 Stearate Phenoxyethanol Polysorbate 20 Resveratrol Sodium Laurylglucosides Hydroxypropylsulfonate Sorbitan Olivate Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Methyl Salicylate 25% (NSAID: Nonsteroidal anti-inflammatory drug)            Topical Analgesic

Purpose

Methyl Salicylate 25% (NSAID: Nonsteroidal anti-inflammatory drug)            Topical Analgesic


Medication Information

Purpose

Methyl Salicylate 25% (NSAID: Nonsteroidal anti-inflammatory drug)            Topical Analgesic

Description

Methyl Salicylate 25% (NSAID: Nonsteroidal anti-inflammatory drug)            Topical Analgesic

Uses

Temporarily relieves mild to moderate aches & pains of muscles & joints associated with:

• strains • sprains • simple backache • arthritis • bruises

Section 50565-1

Section 55105-1

Warnings

For external use only

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding.

The chance is small but higher if you:

• are age 60 or older • have had stomach ulcers or bleeding problems

• take a blood thinning (anticoagulant) or steroid drug

• take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others]

• have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed

Do not use

• on the face or rashes • on wounds or damaged skin • if allergic to aspirin or other NSAIDs

• with a heating pad • when sweating (such as from exercise or heat)

• right before or after heart surgery

Ask a doctor before use if

• you are allergic to topical products • the stomach bleeding warning applies to you

• you have high blood pressure, heart disease, or kidney disease • you are taking a diuretic

When using this product

• wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

• stomach pain or upset gets worse or lasts • you feel faint, vomit blood, or have bloody or black stools

These are signs of stomach bleeding. • rash, itching or skin irritation develops

• condition worsens

• symptoms last for more than 3 days • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a doctor before use while breast-feeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Directions

 • Use only as directed

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily •children under 12 years of age: consult a physician

Product Label

Other Information

• Store at 20-25°C (68-77°F) • Avoid storing product in direct sunlight

•Protect product from excessive moisture

Inactive Ingredients

Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbital olivate, stearic acid

Active Ingredient                                                                                     purpose

Methyl Salicylate 25% (NSAID: Nonsteroidal anti-inflammatory drug)            Topical Analgesic


Structured Label Content

Uses

Temporarily relieves mild to moderate aches & pains of muscles & joints associated with:

• strains • sprains • simple backache • arthritis • bruises

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For external use only

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding.

The chance is small but higher if you:

• are age 60 or older • have had stomach ulcers or bleeding problems

• take a blood thinning (anticoagulant) or steroid drug

• take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others]

• have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed

Do not use

• on the face or rashes • on wounds or damaged skin • if allergic to aspirin or other NSAIDs

• with a heating pad • when sweating (such as from exercise or heat)

• right before or after heart surgery

Ask a doctor before use if

• you are allergic to topical products • the stomach bleeding warning applies to you

• you have high blood pressure, heart disease, or kidney disease • you are taking a diuretic

When using this product

• wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

• stomach pain or upset gets worse or lasts • you feel faint, vomit blood, or have bloody or black stools

These are signs of stomach bleeding. • rash, itching or skin irritation develops

• condition worsens

• symptoms last for more than 3 days • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a doctor before use while breast-feeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Directions

 • Use only as directed

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily •children under 12 years of age: consult a physician

Product Label (Product label)

Other Information (Other information)

• Store at 20-25°C (68-77°F) • Avoid storing product in direct sunlight

•Protect product from excessive moisture

Inactive Ingredients (Inactive ingredients)

Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbital olivate, stearic acid

Active Ingredient                                                                                     purpose (Active Ingredient                                                                                     Purpose)

Methyl Salicylate 25% (NSAID: Nonsteroidal anti-inflammatory drug)            Topical Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)