Active Ingredients
Menthol USP 7%, Camphor USP 2%
Provault Muscle Salve
FDA Label NDC 61577-6300
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 Provault Muscle Salve (NDC 61577-6300). 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
Temporary relief of monor aches and pains of muscles and joints associated with strains, bruises and sprains.
Warnings
For external use only.
Directions
Apply to affected area not more than 3 to 4 times daily. After each application, wash hands with soap and water (unless applying to hands). Children under the age of 18, consult a doctor before use.
Inactive Ingredients
Arnica Montana (Arnica) Flower Extract, Butyrospermum Parkii (Shea) Butter, Calendula officinalis (Calendula) Flower Extract, Cannabidiol (CBD), Chamomilla Recutita Matricaria (Chamomile) Flower Extract, Citrus Medica Limonum (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, (Kosher Vegetable), Hemp Seed Oil, Hydrogenated Cocos Nucilera (Coconut) Oil, Lonicera Japonica (Honeysuckle) Flower Extract, Mentha Avensis (Mint) Leaf Oil.
Questions Or Comments
Call 866 419 0043
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