Bonica Easex Pain Relieving Patch

Bonica Easex Pain Relieving Patch
SPL v1
SPL
SPL Set ID 34f1196a-fda1-4bef-be71-e5a09ee97bc1
Route
TOPICAL
Published
Effective Date 2025-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (31 mg) Menthol (60 mg) Salicylic Acid (100 mg)
Inactive Ingredients
Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Mineral Oil Terpene Resin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Use

For temporary relief of pain

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

• Clean and dry affected area • Carefully remove backing from patch • Apply sticky side of patch to affected area • Use one patch for up to 8 hours • Discard patch after single use • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Children under 12 years of age:consult a physician

Do Not Use

• More than one patch on your body at a time • On cut, irritated or swollen skin • On puncture wounds • For more than one week without consulting a doctor • If you are allergic to any active or inactive ingredients • If pouch is damaged or opened

Drug Facts

Other Information

Store in a clean, dry place outside of direct sunlight        Protect from excessive heat

Package Labeling:

Active Ingredients

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Inactive Ingredients

• A-tocopherol acetate • Antioxidant 1010 • ESIS • Fumed Silica • Mineral Oil • Polyisobutylene • Terpene Resin

When Using This Product

• Use only as directed • Read and follow all directions and warnings • Do not allow contact with the eyes • Do not use at the same time as other topical anesthetics • Do not bandage tightly or apply local heat (such as heating pads) to the area of use • Do not microwave • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can product serious adverse effects is a child or pet chews or ingests this patch.

Stop Use and Ask A Doctor If

• Conditions worsen • Redness is present • Irritation develops • Symptoms persist for more than 7 days or clear up and occur again within a few days • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregant 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 Center right away.


Structured Label Content

Use

For temporary relief of pain

Purpose

Topical analgesic

Warnings

For external use only

Directions

Adults and children 12 years of age and over:

• Clean and dry affected area • Carefully remove backing from patch • Apply sticky side of patch to affected area • Use one patch for up to 8 hours • Discard patch after single use • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily Children under 12 years of age:consult a physician

Do Not Use (Do not use)

• More than one patch on your body at a time • On cut, irritated or swollen skin • On puncture wounds • For more than one week without consulting a doctor • If you are allergic to any active or inactive ingredients • If pouch is damaged or opened

Drug Facts

Other Information (Other information)

Store in a clean, dry place outside of direct sunlight        Protect from excessive heat

Package Labeling:

Active Ingredients (Active ingredients)

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Inactive Ingredients (Inactive ingredients)

• A-tocopherol acetate • Antioxidant 1010 • ESIS • Fumed Silica • Mineral Oil • Polyisobutylene • Terpene Resin

When Using This Product (When using this product)

• Use only as directed • Read and follow all directions and warnings • Do not allow contact with the eyes • Do not use at the same time as other topical anesthetics • Do not bandage tightly or apply local heat (such as heating pads) to the area of use • Do not microwave • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can product serious adverse effects is a child or pet chews or ingests this patch.

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

• Conditions worsen • Redness is present • Irritation develops • Symptoms persist for more than 7 days or clear up and occur again within a few days • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If Pregant Or Breast Feeding, (If pregant 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 Center right away.


Advanced Ingredient Data


Raw Label Data

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