Alo Therapeutic Massage Pain Relieving Cream
FDA Label NDC 51457-001
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Theraplex Solutions for the product Alo Therapeutic Massage Pain Relieving (NDC 51457-001). 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 alo therapeutic massage cream pain relieving, active ingredients, purpose, uses, warnings, • do not apply, • if symptoms persist for more than seven days,, • keep out of reach of children., 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%
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 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.
• 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, Helianthus 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
P.O. BOX 770125
MIAMI, FL 33177
Questions? Call 305.609.4229
www.alopainrelief.com
THIS PRODUCT IS NOT TESTED ON ANIMALS.
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 CIRCULATIONS TO SPEED HEALING
32 f l o z
Alo Therapeutic Massage Cream Pain Relieving 32Oz (51457-001-32)
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