Methyl Salicylate 10% Patch

Methyl Salicylate 10% Patch
SPL v2
SPL
SPL Set ID 11a6d22a-1a7a-4c76-b873-fffd00ac4b54
Route
TOPICAL
Published
Effective Date 2023-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Acrylic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Drug Facts

Uses

Temporarily relieves aches & pains of muscles & joints associated with:

  • Strains
  • Sprains
  • Simple Backache
  • Arthritis
  • Bruises
Section 50565-1

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

Section 53414-9

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.

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 as NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
Directions

Adults and Children 10 years of age and older:

  • only use one patch at a time
  • clean and dry affected area
  • remove patch from backing film and apply to skin (see illustration)
  • apply 1 patch to the affective area of intact skin up to 36 hours.
  • do not use more than 2 patches per day
  • do not use for more than 3 days in a row
  • the used patch should be removed from the skin when a new one is applied
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)
  • any patch from a pouch that has been open for 14 or more days
  • right before or after heat surgery
Other Information
  • Store at 20-25°C (68-77°F)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Some individuals may not experience pain relief until several hours after applying the patch
Active Ingredients:

Methyl Salicylate 10% (NSAID: nonsteroidal anti-inflammatory drug)

Inactive Ingredients

Hypoallergenic Acrylic Adhesive

Questions Or Comments?

833.711.8833

Principal Display Panel

NDC 82944-101-10

METHYL SALICYLATE 10%

Topical Analgesic (NSAID)

TOPICAL PAIN PATCH

For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective

Long Lasting Relief

WATER

RESISTANT

TECHNOLOGY

Qty: 10 Flexible Patches

(5 Per Resealable Pouch) x2

3 x 5 (7.62cm x 12.7cm)

APPLY FOR 36 HOURS

ION PHARMA

MADE IN

USA

When Using This Product
  • wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with the water.
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Ask A Doctor Before Use If
  • you are allergic to topical products
  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have high blood pressure, heart disease or kidney disease
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.

Structured Label Content

Drug Facts

Uses

Temporarily relieves aches & pains of muscles & joints associated with:

  • Strains
  • Sprains
  • Simple Backache
  • Arthritis
  • Bruises
Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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.

Purpose

Topical analgesic

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 as NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
Directions

Adults and Children 10 years of age and older:

  • only use one patch at a time
  • clean and dry affected area
  • remove patch from backing film and apply to skin (see illustration)
  • apply 1 patch to the affective area of intact skin up to 36 hours.
  • do not use more than 2 patches per day
  • do not use for more than 3 days in a row
  • the used patch should be removed from the skin when a new one is applied
Do Not Use (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)
  • any patch from a pouch that has been open for 14 or more days
  • right before or after heat surgery
Other Information (Other information)
  • Store at 20-25°C (68-77°F)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Some individuals may not experience pain relief until several hours after applying the patch
Active Ingredients: (Active ingredients:)

Methyl Salicylate 10% (NSAID: nonsteroidal anti-inflammatory drug)

Inactive Ingredients (Inactive ingredients)

Hypoallergenic Acrylic Adhesive

Questions Or Comments? (Questions or comments?)

833.711.8833

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 82944-101-10

METHYL SALICYLATE 10%

Topical Analgesic (NSAID)

TOPICAL PAIN PATCH

For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective

Long Lasting Relief

WATER

RESISTANT

TECHNOLOGY

Qty: 10 Flexible Patches

(5 Per Resealable Pouch) x2

3 x 5 (7.62cm x 12.7cm)

APPLY FOR 36 HOURS

ION PHARMA

MADE IN

USA

When Using This Product (When using this product)
  • wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with the water.
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Ask A Doctor Before Use If (Ask a doctor before use if)
  • you are allergic to topical products
  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have high blood pressure, heart disease or kidney disease
Stop Use and Ask A Doctor If (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.

Advanced Ingredient Data


Raw Label Data

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