SPL v1
SPL
SPL Set ID 2dd5226c-e7e0-cca0-e063-6394a90a32a5
Route
TOPICAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Edetate Disodium Kaolin Methylparaben Sodium Polyacrylate (8000 Mw) Carboxymethylcellulose Sodium Glycerin Water Polysorbate 80 Alpha-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-10

Description

Adults and children 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. Clean and dry affected area Open pouch and remove one patch Remove any protective film and apply directly to affected area of pain. Apply immediately after removal form the protective envelope. Wash hands with soap and water after handling the patches. Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. Fold used patches so that the adhesive side sticks to itself and safely discard used patches of pieces of cut patches where children and pets cannot get to them. Children under 18 years: Ask a physician

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Adults and children 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. Clean and dry affected area Open pouch and remove one patch Remove any protective film and apply directly to affected area of pain. Apply immediately after removal form the protective envelope. Wash hands with soap and water after handling the patches. Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. Fold used patches so that the adhesive side sticks to itself and safely discard used patches of pieces of cut patches where children and pets cannot get to them. Children under 18 years: Ask a physician

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

CONSULT PHYSICIAN FOR CHILDREN UNDER 18.

Section 51945-4

Warnings

For external use only. Use only as directed or as directed by a healthcare professional. Read all warnings and directions before us. Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

Directions

Adults and children 18 years of age and older:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

  • Clean and dry affected area
  • Open pouch and remove one patch
  • Remove any protective film and apply directly to affected area of pain. Apply immediately after removal form the protective envelope.
  • Wash hands with soap and water after handling the patches.
  • Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.

Fold used patches so that the adhesive side sticks to itself and safely discard used patches of pieces of cut patches where children and pets cannot get to them.

Children under 18 years: Ask a physician

Do Not Use
  • On wounds, cuts, damaged or infected skin
  • On eyes, mouth, genitals, or any other mucous membranes

Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.

Active Ingredient

Methyl Salicylate 10%

Other Information

May be applied under occlusive dressing.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C(59-86°F). See USP Controlled Room Temparature

Inactive Ingredients

Polysorbate 80, Glycerin, Sodium Cellulose Glycolate, Sodium Polyacrylate, Vitamin E, EDTA Disodium Salt, Kaolin, Water, Methylparaben

When Using This Product
  • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensatoin generally disappears after several days.
  • Avoid contact with the eyes, lips, nose and mucous membranes
  • You may experiences a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
  • Avoid contact with the eyes, lips, nose and mucous membranes
  • Do not tightly wrap or bandage the treated area
  • Do no apply heat to the treated area immediately before or after use
Stop Use and Ask A Physician If:
  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

CONSULT PHYSICIAN FOR CHILDREN UNDER 18.

Section 51945-4 (51945-4)

Purpose

External Analgesic

Warnings

For external use only. Use only as directed or as directed by a healthcare professional. Read all warnings and directions before us. Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

Directions

Adults and children 18 years of age and older:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

  • Clean and dry affected area
  • Open pouch and remove one patch
  • Remove any protective film and apply directly to affected area of pain. Apply immediately after removal form the protective envelope.
  • Wash hands with soap and water after handling the patches.
  • Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.

Fold used patches so that the adhesive side sticks to itself and safely discard used patches of pieces of cut patches where children and pets cannot get to them.

Children under 18 years: Ask a physician

Do Not Use (Do not use)
  • On wounds, cuts, damaged or infected skin
  • On eyes, mouth, genitals, or any other mucous membranes

Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.

Active Ingredient

Methyl Salicylate 10%

Other Information

May be applied under occlusive dressing.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C(59-86°F). See USP Controlled Room Temparature

Inactive Ingredients

Polysorbate 80, Glycerin, Sodium Cellulose Glycolate, Sodium Polyacrylate, Vitamin E, EDTA Disodium Salt, Kaolin, Water, Methylparaben

When Using This Product (When using this product)
  • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensatoin generally disappears after several days.
  • Avoid contact with the eyes, lips, nose and mucous membranes
  • You may experiences a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
  • Avoid contact with the eyes, lips, nose and mucous membranes
  • Do not tightly wrap or bandage the treated area
  • Do no apply heat to the treated area immediately before or after use
Stop Use and Ask A Physician If: (Stop use and ask a physician if:)
  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Advanced Ingredient Data


Raw Label Data

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