Reme D
FDA Label NDC 54162-560

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Corp for the product Reme D (NDC 54162-560). 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 drug facts, uses, instructions for use, warnings, otc - keep out of reach of children, storage and handling, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients                              Purpose

Menthol 5%                                     Topical Analgesic

Capsaicin 0.025%                            Topical Analgesic

Uses

For temporary relief of minor aches & pains of muscles & joints associated with arthritis, simple backache, strains, bruises, and sprains.

Instructions For Use

Clean and dry the affected area.

Open pouch and remove one patch.

Remove any protective film and apply directly to affected area of pain. Apply immedi-ately after removal from the protective envelope.

Wash hands with soap and water after handling the patches.

Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.

Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.

Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them

Warnings

 

For external use only.

Use only as directed or by a health professional

Do not use: On wounds, cuts, damaged or infected skin. On eyes, mouth, genitals, or any other mucous membranes.

Stop and consult your physician if pregnant or pain worsens.

Allergy Alert: If you are allergic to any ingredients of this product or chili peppers contact a doctor before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Consult physician for children under 12.

Storage And Handling

Storage Condition 15°-30°C (59°-86°F)

Dosage & Administration

Discontinue use at least 1 hour befor a bath or shower and do not use immediately after a bath or shower.

Package Label.Principal Display Panel

Label Of Patch (Rdp7g)

Label Of Patch (Rdp7g)

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