Otc - Active Ingredient
menthol
Solcure Thera Roll Hot Pro
FDA Label NDC 83235-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Erae Natural Life for the product Solcure Thera Roll Hot Pro (NDC 83235-0002). 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 otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Water
Ethanol
Chamaecyparis Obtusa Water
Dipropylene Glycol
Glycerin
Illite Extract
Butylene Glycol
Vincetoxicum Atratum Extract
Sodium Polyacrylate
Laureth-7
C13-14 Isoalkane
Vanillyl Butyl Ether
Fragrance
Otc - Purpose
therapy by warming & relaxing
Otc - Keep Out Of Reach Of Children
keep out or reach of the children
Indications & Usage
Apply an appropriate amount as if massaging before and after exercise (except for the face and sensitive body parts)
Warnings
This product is for exeternal use only. Do not use for internal use
Storage and handling precautions
If possible, avoid direct sunlight and store in cool and area of low humidity in order to maintain the quality of the product and avoid misuse
Avoid placing the product near fire and store out in reach of children
- consult a physician in case of abnormal symptoms, such as red spots, swelling or itching, or side effects in the areas of application due to direct light during or after using the product
- do not use on wounded area
Dosage & Administration
for external use only
Package Label.Principal Display Panel
Label (Label)
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