SPL v1
SPL
SPL Set ID 2c0fbfa3-b5fd-e597-e063-6394a90a82f3
Route
TOPICAL
Published
Effective Date 2025-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g) Camphor (natural) (1 g)
Inactive Ingredients
Ethylene-vinyl Acetate Copolymer (28% Vinyl Acetate) Cotton

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-20

Description

Active ingredients Menthol Camphor (natural)

Purpose

Temporary relief of minoraches & pains in variousjoints and muscles. Single-Use Application Easy to Apply and Remove. Stay-Put Flexible Patch No-Mess Application Lasts Up to 8 Hours


Medication Information

Purpose

Temporary relief of minoraches & pains in variousjoints and muscles.

Single-Use Application

Easy to Apply and Remove.

Stay-Put Flexible Patch

No-Mess Application

Lasts Up to 8 Hours

Description

Active ingredients Menthol Camphor (natural)

Use

When using this productUse only as directed

◆Read and follow all instructions andwarnings on this box

◆ Do not contact eyes

◆ Do not use at the same time as other topicalpainkillers

Do not apply tight bandages or localizedheat (e.g. heating pads) to the area ofapplicationDo not microwave used patches

◆Always keep product away from childrenand petsUsed patches still contain drug productsand may cause serious adverse reactions ifchildren or pets bite or swallow the patch

Dosage

DirectionsAdults and children 12 years of age and over:Clean and dry affected areaRemove the patch from the filmApply to the affected area not more than 3to 4 times dailyRemove the patch from the skin after atmost 8 hours of applicationChildren under 12 years of age:Consult a doctor

Section 51945-4

Section 55106-9

Active ingredients

Menthol

Camphor (natural)

Warnings

WarningsFor disposable for external use

Directions

DirectionsAdults and children 12 years of age and over:Clean and dry affected areaRemove the patch from the filmApply to the affected area not more than 3to 4 times dailyRemove the patch from the skin after atmost 8 hours of applicationChildren under 12 years of age:Consult a doctor

Do Not Use

Do not use

Allergic to the ingredients of the produc

tPregnant and breastfeeding women Wounds or broken skin

◆Damaged or opened packaging

Stop Using

Stop using and consult a doctor if◆lf symptoms persist for more than 7 daysThe situation worsensSymptoms disappear and reappear withina few daysLocalized skin reactions such as rash,itching, redness, pain, swelling, andblistering occur

Inactive Ingredient

EVA-28

COTTON

Keep Out of Reach of Children

Keep out of reach of children and petslf swallowed, get medical help or contact aPoison Control Center at 1-800-222-1222 rightaway


Structured Label Content

Use

When using this productUse only as directed

◆Read and follow all instructions andwarnings on this box

◆ Do not contact eyes

◆ Do not use at the same time as other topicalpainkillers

Do not apply tight bandages or localizedheat (e.g. heating pads) to the area ofapplicationDo not microwave used patches

◆Always keep product away from childrenand petsUsed patches still contain drug productsand may cause serious adverse reactions ifchildren or pets bite or swallow the patch

Dosage

DirectionsAdults and children 12 years of age and over:Clean and dry affected areaRemove the patch from the filmApply to the affected area not more than 3to 4 times dailyRemove the patch from the skin after atmost 8 hours of applicationChildren under 12 years of age:Consult a doctor

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active ingredients

Menthol

Camphor (natural)

Purpose

Temporary relief of minoraches & pains in variousjoints and muscles.

Single-Use Application

Easy to Apply and Remove.

Stay-Put Flexible Patch

No-Mess Application

Lasts Up to 8 Hours

Warnings

WarningsFor disposable for external use

Directions

DirectionsAdults and children 12 years of age and over:Clean and dry affected areaRemove the patch from the filmApply to the affected area not more than 3to 4 times dailyRemove the patch from the skin after atmost 8 hours of applicationChildren under 12 years of age:Consult a doctor

Do Not Use (Do not use)

Do not use

Allergic to the ingredients of the produc

tPregnant and breastfeeding women Wounds or broken skin

◆Damaged or opened packaging

Stop Using (Stop using)

Stop using and consult a doctor if◆lf symptoms persist for more than 7 daysThe situation worsensSymptoms disappear and reappear withina few daysLocalized skin reactions such as rash,itching, redness, pain, swelling, andblistering occur

Inactive Ingredient (Inactive ingredient)

EVA-28

COTTON

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

Keep out of reach of children and petslf swallowed, get medical help or contact aPoison Control Center at 1-800-222-1222 rightaway


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)