Medi-patch With Lidocaine
FDA Label NDC 76074-163

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 76074-163). 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 indications & usage, dosage & administration, inactive ingredient, other safety information, pregnancy, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

Pregnancy

IF PREGNANT OR NURSING ASK A HEALTH PROFESSIONAL BEFORE USE.

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.

Package Label.Principal Display Panel

Medi-patch-rx_153-21_lbl (Medi Patch Rx 153 21 Lbl)

Medi-patch-rx_153-21_lbl (Medi Patch Rx 153 21 Lbl)

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