Active Ingredient
Camphor 80mg
Menthol 24mg
Reinreude Back Pain Therapy Patch
FDA Label NDC 85248-175
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Reinreude Back Pain Therapy (NDC 85248-175). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Patch Topical Analgesic
Use
▆temporarily relieves minor pain associated with: ▆arthritis ▆simple backache▆bursitis ▆tendonitis ▆muscle strains ▆sprains▆bruises ▆cramps
Warnings
For external use only
Do Not Use
▆Use only as directed. Read and follow all directions and warnings on this carton.
▆Avoid contact with eyes and mucous membranes
▆Do not apply to wounds or damaged skin, broken or irritated skin
▆A transient burning sensation may occur upon application but usually disappears within a few days.
When Using
▆Use only as directed. Read and follow all directions and warnings on this carton.
▆Avoid contact with eyes and mucous membranes
▆Do not apply to wounds or damaged skin, broken or irritated skin
▆A transient burning sensation may occur upon application but usually disappears within a few days.
Stop Use
▆condition worsens ▆redness is present ▆irritation develops▆symptoms persist for more than 7 days or clear up and occur again within a few dsys
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Ask Doctor
▆condition worsens ▆redness is present ▆irritation develops▆symptoms persist for more than 7 days or clear up and occur again within a few dsys
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep Out Of Reach Of Children
Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away
Directions
adults and children over 12 years.
remove backing from patch by firmly grasping both ends and gently pulling until backing separate in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area Wear one patch for up to 8 hours.
Repeat if needed, but do not use more than 3 times daily.
children 12 years or younger: ask a doctor
Inactive Ingredients
water, aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, Starch, talc, tartaric acid, titanium dioxide.
Principal Display Panel
80 (C2599e47216e044f05b742b82da7f561)
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