Active Ingredients
Menthol USP 3%
Camphor USP 3%
Muscle Ease Gel
FDA Label NDC 61577-2301
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 Inc. for the product Muscle Ease (NDC 61577-2301). 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
| EXTERNAL ANALGESIC
|
|---|
Keep Out Of Reach Of Children
Keep out of reach of children
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, and sprains
Warnings
For external use only. Do not use on wounds or damaged skin. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children.
Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.
Directions
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed,
children under 2 years of age: consult a doctor.
Inactive Ingredients
aloe vera extract, capsaicin, carbomer, decyl polyglucose, water, grapefruit seed extract, green tea extract, orange peel extract, queen of the prairie extract, rose water, sodium hydroxymethylglycinate, vegetable glycerin, witch hazel, yucca extract
Questions Or Comments
1-800-225-3963
Package Label.Principal Display Panel
Mm1 (Mm1)
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