Active Ingredient
Lidocaine 4%
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Reinreude Provides Temporary Relief For Minor Muscle And Joint Pain (NDC 85248-076). 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.
Lidocaine 4%
Pain Relief
▆temporarily relieves minor pain associated with: ▆arthritis ▆simple backache▆bursitis ▆tendonitis ▆muscle strains ▆sprains▆bruises ▆cramps
For external use only
▆use only as directed. Read and follow all directions and warnings on this carton. ▆avoid contact with eyes and mucous membranes ▆rare cases of serious burns have been reported with products of this type ▆ do not apply to wounds or damaged skin, broken or irritated skin ▆do not bandage tightly or apply local heat (such as heating pads) to the area of use ▆ A transient burning sensation may occur upon application but usually disappears within a few days.
▆use only as directed. Read and follow all directions and warnings on this carton. ▆avoid contact with eyes and mucous membranes ▆rare cases of serious burns have been reported with products of this type ▆ do not apply to wounds or damaged skin, broken or irritated skin ▆do not bandage tightly or apply local heat (such as heating pads) to the area of use ▆ A transient burning sensation may occur upon application but usually disappears within a few days.
▆condition worsens ▆redness is present ▆irritation develops▆symptoms persist for more than 7 days or clear up and occur again within a few dsys ▆you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding. ask a health professional before 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 ▆you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away
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
water, aluminym hvdroxide, cellulose gum, glvcerin, isopropyl myristate, nonoxynol-30, polyacrylic aciopolysorbate 80, sodium polvacrvlate, sorbitan sesauioleate,Starch, talc, tartaric acid,titanium dioxide
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