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

Purpose

Topical analgesic

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%


Medication Information

Warnings

For external use only

Purpose

Topical analgesic

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

Other Information

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

Inactive Ingredients

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

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Use

For temporary relief of pain

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

Package Labeling:

Active Ingredients

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

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

Warnings

For external use only

Purpose

Topical analgesic

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Use

For temporary relief of pain

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

Package Labeling:

Active Ingredients (Active ingredients)

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

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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