Eagle Brand Medicated Plaster Extra Strength

Eagle Brand Medicated Plaster Extra Strength
SPL v2
SPL
SPL Set ID 2f2a4080-d538-1c6a-e063-6394a90ae51c
Route
TOPICAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g) Menthol (1.25 g)
Inactive Ingredients
Titanium Dioxide Polyacrylic Acid (8000 Mw) Glycerin Polysorbate 80 Petrolatum Carboxymethylcellulose Sodium Sodium Polyacrylate (2500000 Mw) Tartaric Acid, D- Mineral Oil Kaolin Iodopropynyl Butylcarbamate Dihydroxyaluminum Aminoacetate Phenoxyethanol Water Propylene Glycol Povidone Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-01

Description

Menthol 1.25% Capsaicin 0.025%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Menthol 1.25% Capsaicin 0.025%

Uses

For temporary relief of minor aches and pains of muscles and joints associated with ▪ simple backache ▪ arthritis ▪ strains ▪ bruises ▪ sprains.

Warnings

For external use only

Directions

Adults and children 12 years of age and above:

▪ Clean and dry affected area before applying.

▪ Do not leave the patch on skin for more than 8 hours.

▪ Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age:

▪ Do not use, consult a doctor.

Questions?

If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.

Package Label

5 Patches in 1 Pouch NDC: 43405-301-05

Other Information

▪ Avoid storing product in direct sunlight.

▪ Protect product from excessive moisture.

Active Ingredients
  • Menthol 1.25%
  • Capsaicin 0.025%
Inactive Ingredients

Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Glycerin, Iodopropynyl butylcarbamate, Kaolin, Mineral oil, Petrolatum, Phenoxyethanol, Polyacrylic acid, Polysorbate, Povidone, Propylene glycol, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol

When Using This Product

▪ Avoid contact with eyes or on mucous membranes.

▪ Do not apply to wounds or damaged skin.

▪ Do not bandage tightly.

▪ Do not apply wiht external heat, such as heating pad.

▪ Do not use otherwise than as directed

Stop Use and Ask Doctor If

▪ Condition worsens.

▪ Symptoms persist for more than 7 days.

▪ Clear up and occur again within a few days, discontinue use of this product and consult a doctor.

▪ Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occurs.

If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Centre right away.


Structured Label Content

Uses

For temporary relief of minor aches and pains of muscles and joints associated with ▪ simple backache ▪ arthritis ▪ strains ▪ bruises ▪ sprains.

Purpose

External Analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and above:

▪ Clean and dry affected area before applying.

▪ Do not leave the patch on skin for more than 8 hours.

▪ Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age:

▪ Do not use, consult a doctor.

Questions?

If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.

Package Label

5 Patches in 1 Pouch NDC: 43405-301-05

Other Information (Other information)

▪ Avoid storing product in direct sunlight.

▪ Protect product from excessive moisture.

Active Ingredients (Active ingredients)
  • Menthol 1.25%
  • Capsaicin 0.025%
Inactive Ingredients (Inactive ingredients)

Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Glycerin, Iodopropynyl butylcarbamate, Kaolin, Mineral oil, Petrolatum, Phenoxyethanol, Polyacrylic acid, Polysorbate, Povidone, Propylene glycol, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol

When Using This Product (When using this product)

▪ Avoid contact with eyes or on mucous membranes.

▪ Do not apply to wounds or damaged skin.

▪ Do not bandage tightly.

▪ Do not apply wiht external heat, such as heating pad.

▪ Do not use otherwise than as directed

Stop Use and Ask Doctor If (Stop use and ask doctor if)

▪ Condition worsens.

▪ Symptoms persist for more than 7 days.

▪ Clear up and occur again within a few days, discontinue use of this product and consult a doctor.

▪ Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occurs.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Centre right away.


Advanced Ingredient Data


Raw Label Data

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