Alo Therapeutic Massage Cream
FDA Label NDC 71061-764

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cmi Therapy Solutions for the product Alo Therapeutic Massage (NDC 71061-764). 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 ingredients, uses, warnings, do not apply, keep out of reach of children., if pregnant or breast feeding,, directions, other ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 3.00%

Histamine Dihydrochloride 0.100%

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 damaged 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 affected 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, Helianthus Annuus (Sunflower) Oil, Mentha Viridis (Spearmint) Oil, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, SD-Alcohol 40B, Triethanolamine, Xanthan Gum.

Package Labeling:

Label2 (Label2)

Label2 (Label2)

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