Active Ingredients
Menthol USP 3%, Camphor USP 3%
Tonys Warm Therapy
FDA Label NDC 61577-1400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics for the product Tonys Warm Therapy (NDC 61577-1400). 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, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
External Analgesic
Keep Out Of Reach Of Children
Keep out of reach of children
Uses
Temporarily relieves minor arches and pains of muscles and joints associated with: arthritis, simple backaches.
Warnings
For external use only. Do not use on wounds or damage skin. When using this product : avoid bandaging tightly, aviod contact with eyes, keep out of mreach of childern.
Stop use and ask doctor if : condition worsens, symptoms persist for more than 7 days, clear up and within a few days.
Directions
adults and childern 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughtly until gel is absorbed, Childern under 2 years of age: consult a doctor.
Inactive Ingredients
aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, camellia sinensis (green tea) leaf extract, citrus aurantium dulcis (orange) peel oil, spiraea ulmaria flower (queen of the prairie) extract, rosa damascena flower water, sodium carbonate, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, phenoxyethanol, caprylyl glycol, capsicum annuum fruit extract
Questions Or Comments
1-800-225-3963
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