Alivio Medicated Pain
FDA Label NDC 69512-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alivio Medical Products, Llc for the product Alivio Medicated Pain (NDC 69512-001). 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, uses:, warnings:, do not, keep out of reach of children, if pregnant or breast feeding,, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 5.00%

Capsacin 0.03%

Purpose

External Analgesic

External Analgesic

Uses:

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

Warnings:

  • For external use only.
  • Avoid contact with eyes.

Do Not

  • apply to open wounds or damages skin.
  • bandage tightly
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children

If swallwed, consult physician.

If Pregnant Or Breast Feeding,

contact physician prior to use.

Directions:

  • Clean and dry affected area.
  • Remove patch from backing and apply to affected area.  Apply directly to effected area.
  • Use only on patch at a time, and a maximum of four patches per day.
  • Leave patch on affected area for up eight hours.
  • Do not use patches for more than five consecutive days.
  • Children under 12 should consult a physician prior to use.

Other Ingredients:

acrylic acid ,aluminum hydroxide .carmellose sodium 2-ethylhexyl acrylate .glycerin . isopropyl myristate .methyl acrylate

nonoxynol-30 .polyacrylate.polyacrylic acid .polysorbate 80 sorbitan sesquioleate starch .talc .tartaric acid. titanium dioxide. water (245-114)

Store

at room temperature.  Avoid direct sunlight

Package Label

Alivio Patch

MEDICATED PAIN PATCH

15 PATCHES

Distributed by:

Alivio Medical Products

Hollywood, FL 33020

Aliviopatch2 (Aliviopatch2)

Aliviopatch2 (Aliviopatch2)

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