Otc - Active Ingredient
CAPSAICIN 0.035%
LIDOCAINE 0.5%
MENTHOL 5%
METHYL SALICYLATE 20%
Medi-patch With Lidocaine
FDA Label NDC 76074-153
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Two Hip Consulting, Llc for the product Medi-patch With Lidocaine (NDC 76074-153). 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, otc - purpose, indications & usage, dosage & administration, inactive ingredient, other safety information, otc - questions, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE
TOPICAL ANALGESIC
TOPICAL ANESTHETIC
Indications & Usage
USES: FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, SIMPLE BACKACHE, STRAINS, SPRAINS, MUSCLE SORENESS AND STIFFNESS.
Dosage & Administration
DIRECTIONS:
USE AS DIRECTED. PRIOR TO USE, CLEAN AND DRY AFFECTED AREA. REMOVE PROTECTIVE FILM AND APPLY DIRECTLY TO AFFECTED AREA. DO NOT USE MORE THAN 3 TIMES A DAY. THOROUGHLY WASH HANDS AFTER APPLICATION. RESEAL POUCH AFTER OPENING.
Inactive Ingredient
Inactive Ingredients: ACRLIC ACID, ALUMINUM HYDROXIDE, CARMELLOSE SODIEM, 2-ETHYLHEXYL ACRYLATE, GLYCERIN, ISOPROPYL MYRISTATE, METHYL ACRYLATE, NONOXYNOL-30, POLYACRYLATE, POLYACRYLIC ACID, POLYSORBATE 80, SORBITAN SESQUIOLEATE, STARCH, TALC, TARTARIC ACID, TITANIUM DIOXIDE, WATER.
Other Safety Information
OTHER INFORMATION: STORE BELOW 90°F/32°C
Otc - Questions
QUESTIONS? 888 907-2833
Otc - Ask Doctor
IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A DOCTOR.
Pregnancy
IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
Warnings: For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not use with heating devices or pads. Do not cover or bandage tightly. If swallowed, call poison control. If contact does occur with eyes rinse with cold water and call a doctor.
Otc - Do Not Use
DO NOT USE:
- ON WOUNDS OR DAMAGED SKIN.
- CHILDREN UNDER 12 YEARS OLD, CONSULT A DOCTOR.
- IF YOU ARE ALLERGIC TO ANY INGREDIENTS IN THIS PRODUCT.
Package Label.Principal Display Panel
Medi-patch-rx_153-21_lbl (Medi Patch Rx 153 21 Lbl)
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