Topical Pain Relief

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (20 g) Menthol (5 g) Capsaicin (.0355 g)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Cetostearyl Alcohol Glyceryl Monostearate Fd&c Green No. 3 Hypromellose 2208 (100000 Mpa.s) Isopropyl Palmitate Methylisothiazolinone Phenoxyethanol Polysorbate 60 Propylene Glycol Sodium Hydroxide Stearyl Alcohol Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2011-01-15

Medication Information

Warnings and Precautions

Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor. Do not use: on cuts or infected skin, on children less than 12 years old, in combination with other topical pain products, if allergic to any ingredients, PABA, aspirin products, or sulfa. Do not use if you are pregnant or nursing. Store below 90 degrees F/32 degrees C. See USP Controlled Temperature.

Indications and Usage

Discontinue use and consult a physician if condition worsens or irritation develops. Pain persists for more than 7 days. If pain clears up and then redevelops.

Dosage and Administration

Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

How Supplied

Product: 50436-9990

NDC: 50436-9990-1 120 g in a BOTTLE

Description

Active ingredients Purpose Methyl salicylate 20% (16gm) Topical Analgesic Menthol 5% (4gm) Topical Analgesic Capsaicin 0.035% (0.3gm) Topical Analgesic

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients: Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, sodium Hydroxide, Stearyl Alcohol, Water.

Section 55105-1

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness. This product does not cure any diseases.

Section 55106-9

Active ingredients                               Purpose

Methyl salicylate 20% (16gm)            Topical Analgesic

Menthol 5% (4gm)                             Topical Analgesic

Capsaicin 0.035% (0.3gm)                 Topical Analgesic

Topical Pain Relief (methyl Salicylate, Menthol, Capsaicin) Cream

Structured Label Content

Indications and Usage (34067-9)

Discontinue use and consult a physician if condition worsens or irritation develops. Pain persists for more than 7 days. If pain clears up and then redevelops.

Dosage and Administration (34068-7)

Directions: Use only as directed. Prior to first use, test skin sensitivity by applying a small amount. Apply and massage directly to affected area. Do not use more than 4 times a day. Thoroughly wash hands after application.

Warnings and Precautions (34071-1)

Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor. Do not use: on cuts or infected skin, on children less than 12 years old, in combination with other topical pain products, if allergic to any ingredients, PABA, aspirin products, or sulfa. Do not use if you are pregnant or nursing. Store below 90 degrees F/32 degrees C. See USP Controlled Temperature.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients: Carbomer, Cetearyl Alcohol, Cypress Oil, Glyceryl Stearate, Green 3 (CI# 42053), Hypromellose, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol, Polysorbate-60, Propylene Glycol, sodium Hydroxide, Stearyl Alcohol, Water.

Section 55105-1 (55105-1)

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness. This product does not cure any diseases.

Section 55106-9 (55106-9)

Active ingredients                               Purpose

Methyl salicylate 20% (16gm)            Topical Analgesic

Menthol 5% (4gm)                             Topical Analgesic

Capsaicin 0.035% (0.3gm)                 Topical Analgesic

How Supplied (HOW SUPPLIED)

Product: 50436-9990

NDC: 50436-9990-1 120 g in a BOTTLE

Topical Pain Relief (methyl Salicylate, Menthol, Capsaicin) Cream (TOPICAL PAIN RELIEF (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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