Otc - Active Ingredient
Active ingredients
Menthol
Camphor (natural)
Pain Relief Patch
FDA Label NDC 85152-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henan Hengchuntang Pharmaceutical Co., Ltd for the product Pain Relief (NDC 85152-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose, use, inactive ingredient, do not use, stop using, keep out of reach of children, dosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
Inactive Ingredient
EVA-28
COTTON
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
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
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
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
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