Alo Therapeutic Massage Cream
FDA Label NDC 51457-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Theraplex Solutions for the product Alo Therapeutic Massage (NDC 51457-000). 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, active ingredients, purpose, uses, warnings, 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

Drug Facts


Active Ingredients

Menthol                                   3.00%

Histamine Dihydrochloride    0.100%  

Purpose

External Analgesic

Uses

For temporary relief of minor aches and pains associated with backache, arthritis, bruises and sprains.

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • Do not apply to open wounds or damages skin.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

If swallowed, consult physician.  Do not bandage tightly.

If Pregnant Or Breast Feeding,

contact physician prior to use.

Directions

  • Apply directly to effected area.
  • Do not use more than four times per day.

Other Ingredients

Aqua (Deionized Water), Butylene Glycol, Carbomer, Cetyl Alcohol, Ethylhexylglycerin, Dimethyl Sulfone(MSM), Glyceryl Stearate, Healianthus Annuus (Sunflower) Oil, Mentha Viridis (Spearmint) Oil, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, SD-Alcohol 40B, Triethanolamine, Xanthan Gum.

Distributed By:

THERAPLEX SOLUTIONS

Miami, Florida 33298  

Questions?  call 305.609.4229

www.alo-21.com

Package Label.Principal Display Panel

Alo THERAPEUTIC MASSAGE CREAM; PAIN RELIEVING; DEEP PENETRATING, PAIN RELIEF FROM
ARTHRITIS; SORE MUSCLES AND JOINTS; BACK PAIN;BRUISES AND SPRAINS STIMULATES CIRCULATION TO SPEED HEALING 4 fl oz Drug Facts

Alo Therapeutic Massage Cream 4Oz/118G (51457-000-04)

Alo 1 (Alo1)

Alo 1 (Alo1)

Alo 2 (Alo2)

Alo 2 (Alo2)

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