Eagle Brand Medicated Plaster

Eagle Brand Medicated Plaster
SPL v1
SPL
SPL Set ID 1026ba99-531a-c3be-e063-6294a90a0af4
Route
TOPICAL
Published
Effective Date 2024-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g) Salicylic Acid (1 g)
Inactive Ingredients
Sesame Oil Frankincense Myrrh Zinc Oxide Yellow Ob Fd&c Blue No. 2 Pinus Massoniana Resin Clematis Chinensis Root Yellow Wax Momordica Cochinchinensis Seed Ricinus Communis Seed

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-06

Description

Menthol 5.0% Methyl Salicylate 1.0%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Menthol 5.0% Methyl Salicylate 1.0%

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 Pouch NDC: 43405-300-05

Other Information

▪ Avoid storing product in direct sunlight.

▪ Protect product from excessive moisture.

Active Ingredients

Menthol 5.0%

Methyl Salicylate 1.0%

Inactive Ingredients

Clematis chinensis root, FD&C Blue No.2, Frankincense, Momordica cochinchinensis seed, Myrrh, Pinus massoniana resin, Ricinus communis seed, Sesame oil, Yellow OB, Yellow wax, Zinc oxide

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 A 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 Pouch NDC: 43405-300-05

Other Information (Other information)

▪ Avoid storing product in direct sunlight.

▪ Protect product from excessive moisture.

Active Ingredients (Active ingredients)

Menthol 5.0%

Methyl Salicylate 1.0%

Inactive Ingredients (Inactive ingredients)

Clematis chinensis root, FD&C Blue No.2, Frankincense, Momordica cochinchinensis seed, Myrrh, Pinus massoniana resin, Ricinus communis seed, Sesame oil, Yellow OB, Yellow wax, Zinc oxide

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 A Doctor If (Stop use and ask a 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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